513 Regulatory Affairs Managers jobs in India

**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
**Responsibilities:**
The Regulatory Affairs Manager is responsible for premarket approvals and post market vigilance of the In-Vitro Diagnostic / Medical Devices within LSG in South Asia (SA) market, and for providing knowledgeable input to interdisciplinary the project teams and management.
+ Conduct regulatory submissions for LSG In-Vitro Diagnostic and Medical Devices in South Asia, ensuring timelines and standards are met.
+ Support the implementation of regulatory activities at the LSG Indian plant, ensuring compliance with QMS/GMP.
+ Collaborate with R&D, operations, QA, and product managers to meet regulatory and compliance requirements.
+ Conduct regulatory investigations and analyses, defining strategies and providing updates to cross-functional teams.
+ Prepare and manage technical files/dossiers for regulatory products, supporting global registration applications.
+ Lead local performance evaluations, tests, and clinical studies to support product registration in India.
+ Participate in Animal Health regulatory submissions and support the distributed team as needed.
+ Coordinate post-market surveillance, resolving technical complaints and implementing corrective actions.
+ Review advertisement materials for compliance with MD/IVD regulations in South Asia.
+ Analyze new and existing regulations, preparing impact assessments for LSG projects.
+ Provide regulatory and scientific advice within the Global/APAC LSG Regulatory Affairs organization.
+ Participate in regulatory/quality audits, exhibitions, and conferences.
+ Establish and maintain a network with consultants, policymakers, and regulatory agencies, such as Indian CDSCO.
+ Perform other tasks as assigned by the line manager.
**Minimum Requirements:**
Education and Qualifications:
+ Bachelor's degree or higher in Engineering, Sciences, or Medicine.
+ Over 10 years of experience in regulatory affairs related to Medical Devices and/or In Vitro Diagnostic Devices, particularly with Indian CDSCO regulations.
**Essential Skills and Abilities:**
+ Comprehensive understanding of regulations, standards, and guidelines for In-Vitro Diagnostic and Medical Devices, especially in South Asia and Indian CDSCO regulations.
+ Acute awareness of regulatory changes and skilled in regulatory and strategic analysis.
+ Strong planning and organizational skills for regulatory submissions and project management.
+ Excellent communication skills, including written, verbal, and presentation abilities.
+ Strong project management skills with the ability to lead regulatory projects.
+ Strong analytical skills, proactive, and a resourceful problem solver.
+ Ability to work effectively under pressure and manage flexible working hours.
+ Comfortable with ambiguity and change, providing clear mentorship in uncertain regulatory environments.
+ Experience in leading compliance activities, including post-market surveillance and advertisement review.
+ Ability to establish and maintain a network with relevant consultants, policymakers, and regulatory agencies.
+ Proficiency in working cross-functionally to ensure regulatory and compliance requirements are met.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Mgr Regulatory Affairs
Date: Oct 4, 2025
Location:
Bangalore, India,
Company: Teva Pharmaceuticals
Job Id: 63860
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
+ Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
+ Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
+ Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.
.
**How you'll spend your day**
Regulatory Submissions
+ Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.
+ Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.
+ Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)
Regulatory Intelligence/Expertise/Guidance/Education
+ Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities
+ Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams.
+ Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.
+ Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.
+ Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.
+ Work closely with market RA in APAC region to complete all assigned activities
**Your experience and qualifications**
+ B. Pharm / M. Pharm (preferred) with 10+ years of experience
+ Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.
+ Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran

Dir Regulatory Affairs
Date: Sep 20, 2025
Location:
Navi Mumbai, India,
Company: Teva Pharmaceuticals
Job Id: 63035
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
The Director, Regulatory Affairs - Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U.S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners.
**How you'll spend your day**
+ Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations.
+ Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences
+ Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams.
+ Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc.
+ Establish and maintain strong relationships with FDA project managers.
+ Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes.
+ Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization.
+ Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning.
+ Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives.
+ Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book.
**Your experience and qualifications**
+ Pharm Dor M. Pharma in a scientific discipline.
+ Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products.
+ Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains.
+ Deep expertise and applied knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards.
+ Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree).
+ Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs.
+ Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance.
+ Demonstrates a basic understanding of pharmaceutical drug development.
+ Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills.
+ Demonstrates excellent verbal and written communication skills.
+ Experience working in a matrixed, multinational environment, as well as with third parties.
+ Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus.
+ Lean Six Sigma certification, or other accreditation related to improving business processes is a plus.
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran

**Job Title:**
Executive Regulatory Affairs
**Business Unit:**
R&D1 Regulatory Affairs
**Job Grade**
G12A
**Location**
Baroda
At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Job Description**
Regulatory submission of new products, renewals, variations, response to queries and Life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals.
**Area of Responsibility**
1. **New submissions/Renewals:**
a.Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
b.Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.
2. **Approval:**
Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
3. **Lifecycle management for drug formulations:**
a. Prepare and review variations as per the country specific requirements to support approval of changes such as API
vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
4. **Regulatory compliance:**
a. Prepare, Review and circulate approval package with product history sheet to stake holders upon receipt of approval and updatethe same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc.
**5 Geographic Scope/ Market** :
MENA-GCC, UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain etc.)
**Travel Estimate**
NA
**Job Requirements**
**Educational Qualification**
Graduate : M.Sc /M.Pharm
**Experience**
_Tenure_ : 1-4 years
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Job Title:**
Executive Regulatory & Business Continuity
**Business Unit:**
R&D1 Regulatory Affairs
**Job Grade**
G12A
**Location**
Panoli
At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Job Description**
1. To evaluate and categories QMS related activities like Change Controls w.r.t. US/EDQM/Europe/UK/Australia/Japan/Korea/CADIFA/China/South Africa guidelines
2. To Review, follow up and compilation of data for submission of USDMF, CEP, DCP, CP, MRP for New DMF submission and DMF-Amendment / Update based on the Planning
3. To Review, follow up and compilation of data for submission of Japan, China, TGA, Canadian. for New DMF submission and DMF-Amendment / Update based on the Planning
4. Compilation of raw data for Registration /re-registration and queries received from authorities for ROW market, such as China, Korea, Taiwan, Indonesia, South Africa.etc
**Travel Estimate**
NA
**Job Requirements**
**Educational Qualification**
Graduate : M.Sc
**Experience**
_Tenure_ : 2-5 years
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

+ Preparation and reviewing of labeling for ANDA and/or NDA applications and labeling query responses in accordance with the USFDA regulations.
+ Preparation of Structured Product Labeling (SPL) for drug listing in accordance with the associated applications and USFDA regulations.
+ Preparation, reviewing, timely submission and coordination of implementation of labeling based on FDA notifications and/or RLD labeling updates.
+ Coordination of labeling related activities with cross functional teams for timely launch of products.
+ Regulatory submission and filings, coordinating final labeling implementation and maintaining labeling artworks using various softwares.
+ Communication with third parties or private label distributors to gather needs and requirements of changes/labeling development.
+ Evaluation and coordinating with departments for REMS requirement for applications.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Relocation Assistance Offered Within Country
Job Number # - Mumbai, Maharashtra, India
**Who We Are**
Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values-Caring, Inclusive, and Courageous-we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
**Brief introduction - Role Summary/Purpose :**
+ This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.
**Responsibilities:**
+ Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
+ Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
+ Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
+ Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
+ Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
+ Update and maintain product registration and ingredients archives, databases and tracking tools.
+ Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
+ Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
+ Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
+ Manage the distribution lists of SOP and the archiving in the documentation system.
Artwork Approval:
+ Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
+ Assist the Regional Regulatory Affairs managers with artwork review and approval
Regulatory intelligence and product advocacy activities:
+ Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
+ Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
+ Track Competent Authority websites and databases for news related to new product registrations.
+ Assist Regional Regulatory team to deliver and manage Regulatory Assessment
**Required Qualifications :**
+ BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
+ Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
+ Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
+ Knowledge of industry practices, techniques and standards.
+ Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.
**Preferred Qualifications:**
+ Good written and verbal communicator with excellent interpersonal skills.
+ Good planning and organizing skills.
+ Ability to work under stress and meet deadlines.
+ Fluency in spoken and written English is mandatory.
+ Fluency in languages is advantageous.
#CPIL #LI-AP1
**Our Commitment to Inclusion**
Our journey begins with our people-developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.
**Equal Opportunity Employer**
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form ( should you require accommodation.
#LI-Hybrid

Relocation Assistance Offered Within Country
# - Mumbai, Maharashtra, India
**Who We Are**
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom's of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill's Pet Nutrition.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children's oral health.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team!
**Brief introduction - Role Summary/Purpose :**
This position will manage and maintain product compliance during the whole life-cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.Engage proactively with diverse cross-functional teams, including R&D, legal, regulatory, and marketing departments, to meticulously develop and rigorously review all ingredient lists. This collaborative effort is crucial to guarantee the utmost accuracy and comprehensiveness of each list, ensuring full compliance with all relevant regulations and internal company standards. The objective is to achieve complete alignment across all stakeholders, from initial concept to final product launch, preventing discrepancies and ensuring transparency.
**Responsibilities:**
+ Responsible for developing/reviewing accurate and comprehensive ingredient lists while collaborating closely with cross-functional stakeholders to ensure alignment and timely updates. Manage and maintain a detailed tracking system to monitor ingredient list status, changes and requirements, facilitating smooth communication and efficient project progress.
+ Work closely with and support the Regional Regulatory Affairs Department in new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
+ Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
+ Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for Authorities and Notified Bodies.
+ Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
+ Update and maintain product registration and ingredients archives, databases and tracking tools.
+ Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products eg cosmetics, home care, consumer goods.
+ Work closely with Global and third party business partners to obtain the relevant documents and information for product dossiers.
+ Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
+ Manage the distribution lists of SOP and the archiving in the documentation system.
Artwork Approval:
+ Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (e.g. INCI and INDI).
+ Assist the Regional Regulatory Affairs managers with artwork review and approval
Regulatory intelligence and product advocacy activities:
+ Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
+ Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
+ Track Competent Authority websites and databases for news related to new product registrations.
+ Assist Regional Regulatory team to deliver and manage Regulatory Assessment
**Required Qualifications :**
+ BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
+ Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
+ Understanding of registration and regulatory requirements in Africa Eurasian and Asia Pacific countries.
+ Knowledge of industry practices, techniques and standards.
+ Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals for managing changes and submissions.
**Preferred Qualifications:**
+ Good written and verbal communicator with excellent interpersonal skills.
+ Good planning and organizing skills.
+ Ability to work under stress and meet deadlines.
+ Fluency in spoken and written English is mandatory.
+ Fluency in languages is advantageous.
#CPIL #LI-AP1
**Our Commitment to Sustainability**
With the Colgate brand in more homes than any other, we are presented with great opportunities and new challenges as we work to integrate sustainability into all aspects of our business and create positive social impact. We are determined to position ourselves for further growth as we act on our 2025 Sustainability & Social Impact Strategy.
**Our Commitment to Diversity, Equity & Inclusion**
Achieving our purpose starts with our people - ensuring our workforce represents the people and communities we serve -and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
**Equal Opportunity**
Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact with the subject "Accommodation Request" should you require accommodation.
#LI-On-site

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
+ Leads or compiles all materials required in submissions, license renewal and annual registrations.
+ Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
+ Monitors and improves tracking / control systems.
+ Keeps abreast of regulatory procedures and changes.
+ May direct interaction with regulatory agencies on defined matters.
+ Recommends strategies for earliest possible approvals of clinical trials applications.
**SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
**Organizational Impact:** Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
**Innovation and Complexity:** Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
**Communication and Influence:** Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**Leadership and Talent Management:** May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
**Required Knowledge and Experience:** Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 1 year of relevant experience.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
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