131 Regulatory Affairs Associates jobs in Mumbai

Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).

Location: Andheri, Mumbai.

Qualification: M. Pharm. (Experienced preferred).

Experience- 1-5 Years

JOB DESCRIPTION – Regulatory Affairs (Domestic)

The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with

experience in FDA related activities. This profile will ensure timely and robust functional/cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution

and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing):

· Prepare registration dossier for procuring certificates/license from local FDA, DCGI and

· FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs

· & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.

· Confirm product formula and label acceptability, as well as the receipt of necessary licenses,

· prior to the release of product.

· Co-ordinate with QC and R&D departments for technical documents (manufacturing

· documents like batch records, specifications, analytical methods, validation reports, and

· stability data) required to be incorporated in the registration dossiers.

· Ensure timely renewal of drug and food licenses maintained by head office and also branch

· offices based at various states in the country.

· Online application for obtaining test license for import purpose.

· Maintain archival of all regulatory permissions.

· Keep abreast of the updates pertaining to regulatory requirements and accordingly

· implement them.

· Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance of Packaging Modules:

· Formulate and implement statutory requirements pertaining to the artworks of the

· products (label, carton, package insert, patient information leaflet, etc.).

· Review the artwork of all packaging material.

· Prepare package insert as per New Drugs and Clinical Trials Rules 2019.

· Pharmacovigilance

· Provide high quality medical writing from planning and coordination of literature research.

· Draft and review PSURs with focus on medical aspects of the products and safety sections.

· Review of Risk Management Plans as per Regulatory requirement.

· Good knowledge in assessing the risk-benefit of a product and identify any gaps in the

· aggregate documents.

· Perform scientific review of aggregate reports / ICSRs produced by PV Associates.

Hi Everyone,

I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.

Please refer below JD and share your profile on

• Experienced in preparing, review and compile regulatory submissions.
• Maintain compliance with US FDA and ICH requirements.
• Should have experienced in pre-submission activity.
• Experienced in CMC.
• Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.
• Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines.
• Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
• Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
• Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
• Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses.
• Review and approve change controls from global manufacturing partners to assess regulatory impact.
• Stay current with FDA guidance, ICH regulations, pharmacopeial requirements, and industry updates.

Thank you!

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.

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.

We're Hiring: Regulatory Affairs CMC Associate

Location: Navi Mumbai

Years of Experience:4+ years

Work from Office

Notice Period: Looking for immediate joiners

Skills Required:

Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.

4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting.

Strong experience in US FDA regulations and ICH guidelines.

Experience in handling pre- and post-approval submissions is required

Interested candidates can share their resumes on

Job Title: Regulatory Affairs

No of Vacancy: 1

Job Location: Andheri West

Years of Experience: 1-4 years

Working Days: Monday to Saturday

Job Summary:

We are seeking a motivated and detail-oriented
Regulatory Affairs Executive
to join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions.

Key Responsibilities:

Conduct
gap analysis
of existing regulatory and technical documentation.

Prepare and maintain regulatory submissions including:

l Device Master Files

l Risk Management Files

l Design History Files

l Clinical Evaluation Reports

l Usability Reports

Draft and update product labeling content such as
Instructions for Use (IFUs)
,
implant cards
, and
declarations
to meet global compliance requirements.

Support
regulatory submissions
for India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets.

Coordinate with cross-functional teams including
Purchase, Accounts, Legal, Marketing
, and
R&D
to gather documentation and resolve queries.

Assist in preparing and submitting responses for
audit-related queries
and regulatory inspections.

Contribute to regulatory strategy for
new product developments
and modifications.

Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training.

Educational Qualifications:

Bachelor's or Master's degree in
Pharmaceutical Sciences
,
Engineering
,
Biotechnology
,
Microbiology
, or a related life science field.

Specialization in
Regulatory Affairs
or
Quality Assurance
preferred.

Experience:

1 to 4 years
of industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences.

Hands-on experience with global and domestic regulatory submissions.

Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential.

Experience or knowledge of
software regulations
is an added advantage.

Key Skills and Competencies:

Strong knowledge of:

Regulatory frameworks
including ISO 13485, EU MDR, and 21 CFR Part 820

Risk management
,
design controls
, and
post-market surveillance

Excellent
documentation, analytical
, and
technical writing skills

Proficient in
Microsoft Office Suite
and digital documentation platforms

Strong interpersonal skills to collaborate with internal departments and external bodies

Soft Skills:

Go-getter attitude
with the willingness to lead and take initiative

High
English proficiency
– both verbal and written

Strong
organizational
and
time management
skills

Ability to work independently and as part of a
cross-functional team.

Fast learner with a proactive mindset for continuous development.

Monday to Saturday working