1,006 Regulatory Affairs Associates jobs in India

The **Regulatory Affairs Specialist** stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs Specialists in medical device companies.

**Main duties of the regulatory affairs specialist**
- Prepare, coordinate and supervise regulatory submissions
- Review product conformance and assure compliance
- Implement different strategies in order to meet evolving regulatory initiatives
- Register products according to provincial guidelines and regulations of third party suppliers
- Keep current with regulations
- Participate in conferences and interdepartmental meetings

**Job Types**: Full-time, Regular / Permanent, Fresher

**Salary**: ₹12,242.20 - ₹43,755.49 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Provident Fund
- Work from home

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Work Location: In person

**Speak with the employer**

DEPARTMENT - **Regulatory affairs**

POSITION - **QA/QC**

EXPERIENCE - 2 to 5 YEARS

Role Location - Kheda.

Industry Type - Cosmetic

**Requirement -**

RA - Preparation of SOP, validation of SOPs, CAPA (Corrective & preventive Action), RCI (Root cause investigation), Documentation, Training on GMP.

Documentation like SMF, Area/machine Qualifications, Validation etc.

Regulatory audit and prepare documentation for WHO, USFDA, MHRA etc.

**TO APPLY**:
**Job Types**: Full-time, Permanent

Pay: Up to ₹650,000.05 per year

**Benefits**:

- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Rotational shift

Supplemental Pay:

- Yearly bonus

Work Location: On the road

Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Specialist to manage and execute global regulatory strategies for drug development programs. This is a fully remote position, requiring extensive knowledge of pharmaceutical regulatory requirements and a meticulous approach to documentation and submissions. You will be responsible for preparing, reviewing, and submitting regulatory dossiers (e.g., IND, NDA, MAA) to health authorities worldwide. This includes ensuring compliance with all applicable regulations, guidelines, and internal procedures. Key responsibilities involve liaising with cross-functional teams (R&D, clinical, manufacturing) to gather necessary information, providing regulatory guidance, and staying abreast of evolving regulatory landscapes. You will also contribute to the development of regulatory submission plans and timelines. The ideal candidate will hold a Bachelor's or Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology) or a related field, with a minimum of 5-7 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and submitting major regulatory filings is essential. Excellent written and verbal communication skills, strong analytical and problem-solving abilities, and a thorough understanding of ICH guidelines and regional regulatory requirements are critical. This is an excellent opportunity to contribute to bringing life-saving medicines to patients globally, with the convenience and flexibility of working remotely.

**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.

+ 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.

**What you will do**
**Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.**
**Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.**
**Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.**
**Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.**
**Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.**
**Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.**
**Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.**
**Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.**
**Determining and communicating submission and approval requirements.**
**What you need:**
**Required-**
**Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent discipline is required.**
**3 - 5 years experience**
**Preferred-**
**Experience with post-market and change management is a distinct advantage**
**RAC Certification is preferred**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System ( which makes everything possible.
The Regulatory Affairs Analyst is part of an international team responsible for supporting global registrations for reagent, instrument and software products, new product development, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements.
This position reports to the Global Regulatory Manager and is part of the LS Global Regulatory affairs Team located in Bangalore and will be an on-site role.
In this role, you will have the opportunity to:
+ Perform registration dossier for all the Life Science Products in all countries (except USA)
+ Participate to gathering the technical documentation for new product development
+ Maintain the adequacy with the regulation for technical documentation
+ Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions.
The essential requirements of the job include:
A Bachelor's degree in areas of life sciences or engineering field with a minimum of 8 - 10 years experience in a regulated medical device/diagnostic industry (less years required with advanced degree).
+ Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean)
+ Experience in supporting filing of pre-market regulatory submissions domestically (Q-Subs, 510ks) and internationally (IVDR; China; ROW Global Registrations).
+ Knowledge of domestic and international quality systems and other standards such as, IVDD/IVDR, ISO 13485, ISO 9001 and other applicable standards and regulations.
+ Experience with Software as a Medical Device (SAMD) and Software as an accessory to a device highly desirable.
Required Competencies:
+ Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
+ Quick adaptability to embrace company culture and flexibility to manage multiple projects at the same time.
+ Ability to participate in meetings outside of regular business hours to support global business.
It would be a plus if you also possess previous experience in:
+ Instrument and software development in the context of medical device
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
This job is also eligible for bonus/incentive pay.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

**Manager - International Regulatory Lead**
**Role Name: Manager - International Regulatory Lead (IRL)**
**Department Name: International Regulatory Team, Global Regulatory Affairs**
**Role GCF: 5A**
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
Role Description
The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to
- optimize product development and regulatory approvals in International countries
- develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
- Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.
- Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
- Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
- Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
- Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
- Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.
- Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
- Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
- Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
- Partners with peers to agree on product strategy including projected submission and approval time.
- Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.
- Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
- Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.
- Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
**Basic Qualifications and Experience**
· Doctorate degree OR
· Master's degree and 3 years of relevant regional regulatory experience OR
· Bachelor's degree and 5 years of relevant regional regulatory experience OR
· Associate degree and 10 years of relevant regional regulatory experience OR
· High school diploma/GED and 12 years of relevant regional regulatory experience.
**Functional Skills**
Must-Have Skills
- Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
- General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills
- Strong communication skills, both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to work effectively with global, local and virtual teams
- High degree of initiative and self-motivation
- Planning and organizing abilities
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Good negotiation and influencing skills.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.