Associate, Regulatory Affairs

2 weeks ago

Mumbai, India Pfizer Full time

The PCO based colleague Executive/ Senior Executive, Regulatory Affairs is mainly responsible for end-to-end regulatory activities i.e. both (Operational & Strategy) for local and imported products of India and India Region Markets i.e. Nepal, Sri Lanka, Bangladesh and Bhutan. She would work to ensure collaborative connectivity with the key stakeholders (e.g. Commercial, Medical & Above Country Colleagues etc.) and product life-cycle management in compliance with local regulations and company Standard Operating Procedures (SOPs) for Pfizer India.

1. Strategic/Policy:

- Delivery on compliance in assuring and fulfilling all the regulatory processes for India and India Agency products marketed for Pfizer India.

2. Operational:

- Regulatory Operations
- Development of relationships with key external agencies.
- Tracking and Analyzing impact for day to day to Regulatory update for India Agency market.
- Analyze data and document requirements and compile dossiers to support new product launches per applicable regulatory rules and procedures.
- Compile documents for renewals, variations, line-extension and maintenance of licenses.
- Coordinate documents from Pfizer global teams for regulatory submissions and approvals.
- Create artworks for new product and also initiate artwork revisions.
- Ensure that all CLD, PLD & LPDs are updated followed by the SOPs guidelines.
- Responsible for keeping customers informed about progress/ delay of approvals.
- Handling other regulatory activities that may be assigned by line manager.
- Monitor compliance and implement corrective actions for ensuring delivery on regulatory benchmarks.
- Ensure updating the regulatory parameters for monthly reports.
- Procure Test License for new product development / line extensions (SKUs’).
- Co-ordinate with the relevant customers (internal / external) for trigger / support to regulatory issues arising out of PGS product manufacturing.
- Co-ordinate with the regulatory liaisoning group to follow up for obtaining /renewal /cancellation of manufacturing licenses and additional product permissions.
- Compile dossiers to support new product launches per applicable regulatory rules and procedures for India Agency market.
- Ensure maintenance of product and license information in the tracking database.
- Coordinate/perform activities related to regulatory submissions and do follow up with relevant distributors to obtain regulatory approvals.
- Coordinate with India agency market distributors for regulatory submission and approvals.
- Coordinate documents from GCMC Hubs for regulatory submissions and approvals.
- Responsible for SCC Form submission (Fill, review and submission).
- Ensure revision of LPDs (Local Product Document) aligned to the source country label revision issued through PfLEET within specified time frame.
- Ensure notification of labeling changes to local regulators and distribution of revised LPD to relevant stakeholders in accordance with SOPs.
- Responsible for maintaining effective communication channel with all stakeholders.
- Ensure maintenance and update of the regulatory databases i.e. (PEARL, GDMS, Epalms-II, PfLEET2 & SCC) and other pertinent details related to PGS and India region (local & imported) products.
- Monitor compliance and implement corrective actions for ensuring delivery on regulatory benchmarks.
- Generate and meet customer expectations on regulatory support and deliverables.
- Contribute to Pfizer’s quality-consciousness and research-based image.
- Demonstrate and promote Pfizer global value system across all interactions.
- Implement technology solutions for enabling better information availability.
- A graduate or post-graduate degree in Pharmacy, Pharmaceutical Medicine, Pharmacology, or any other pharmaceutical regulatory discipline.
- Scientific Degree. A higher degree (MS or Ph.D) may be an advantage but is not essential.
- Pharmacist degree may be mandatory in some countries.
- Appropriate regulatory experience in industry minimum 3-5 years’ experience
- Management Degree (Undergraduate or MBA) may be an advantage.
- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
- General management experience and previous line management and leadership experience at senior management level is essential.
- Proven ability to manage complex regulatory issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Demonstrable experience of effective delivery in a complex matrix environment.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE

  • Associate, Regulatory Affairs

    4 weeks ago

    Mumbai, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country 156756 - 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...

  • Regulatory Affairs Executive/pharmaceutical

    1 month ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai, Vile Parle, Dombivli East Regulatory Affairs Executive Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in the same industry. **Job Description**: - Managing regulatory...

  • Regulatory Affairs Executive/ Veterinary Pharma

    6 days ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience...

  • Regulatory Affairs Executive/veterinary Pharma

    4 weeks ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience...

  • Regulatory Affairs Executive/ Veterinary Pharma

    6 days ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience...

  • Regulatory Affairs Executive

    1 week ago

    Mumbai, India AMPLE LEAP COGNITION & TECHNOLOGIES PVT LTD Full time

    **Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific support Responsibilities and...

  • Regulatory Affairs Executive

    4 days ago

    Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full time

    Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...

  • Regulatory Affairs Executive

    1 month ago

    Mumbai, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...

  • Associate Director Regulatory Affairs Biosimilars

    1 month ago

    Mumbai, India Abbott Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...

  • Associate Director Regulatory Affairs Biosimilars

    1 month ago

    mumbai, India Abbott Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. ...

  • Senior Regulatory Affairs Associate

    2 days ago

    mumbai, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Senior Regulatory Affairs Associate Around 4-8 y ears of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional...

  • Senior Regulatory Affairs Associate

    2 days ago

    Mumbai, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Senior Regulatory Affairs Associate Around 4-8 y ears of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...

  • Executive Regulatory Affairs

    4 weeks ago

    Mumbai, India Hab pharmaceuticals & Research limited Full time

    Key Responsibilities: - Should have 3-5 Years of Experience in Regulatory Affairs - Coordinate with Plant and associated departments to facilitate the dossier requirements. - Review of PVP PVR, Stability, PDR, BMR, and other directly or indirectly linked Quality Section in CTD/ACTD - Experience in handling markets like African Countries, the Philippines,...

  • Executive- Regulatory Affairs Regulatory Intelligence

    2 weeks ago

    Mumbai, Maharashtra, India Apotex Pharmachem India Pvt Ltd Full time

    Apply for Executive Regulatory Affairs, Regulatory Intelligence, Career Progress Consultants in Mumbai for 3 - 6 Year of Experience on

  • Executive- Regulatory Affairs Regulatory Intelligence

    2 weeks ago

    Mumbai, India Apotex Pharmachem India Pvt Ltd Full time

    Apply for Executive Regulatory Affairs, Regulatory Intelligence, Career Progress Consultants in Mumbai for 3 - 6 Year of Experience on TimesJobs.com.

  • Regulatory Affairs Officer

    1 month ago

    Mumbai, India Zieva Farm Pvt Lt Full time

    Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies - Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc. - Provide expert regulatory input...

  • Scientific and Regulatory Affairs Manager, APAC

    3 weeks ago

    mumbai, India Ingredion India Private Limited Full time

    Reports to: Head of Scientific & Regulatory Affairs, APAC Location : Mumbai/ Gurgaon, Delhi Direct reports: None Workplace type : Hybrid The Scientific & Regulatory Affairs (SRA) Manager, APAC, should be comfortable to travel between the two cities, as required. The ideal candidate would be experienced with multi-national ingredient...

  • Scientific and Regulatory Affairs Manager, APAC

    1 month ago

    Mumbai, India Ingredion India Private Limited Full time

    Reports to: Head of Scientific & Regulatory Affairs, APAC Location : Mumbai/ Gurgaon, Delhi Direct reports: None Workplace type : Hybrid The Scientific & Regulatory Affairs (SRA) Manager, APAC, should be comfortable to travel between the two cities, as required. The ideal candidate would be experienced with multi-national ingredient or...

  • Regulatory Affairs Intern

    4 weeks ago

    Powai, Mumbai, Maharashtra, India HaystackAnalytics Full time

    **Responsibilities** - Support in creating regulatory and quality policy plan as needed internally and externally - Work with internal personnel and external agencies to implement relevant regulatory requirements - Maintain and submit regular follow up documentation to regulatory/ quality agencies and participate in audits as needed - Document review and...

  • Director Regulatory Affairs

    3 weeks ago

    mumbai, India Abbott Full time

    CORE JOB RESPONSIBILITIES Primary Function/Primary Goals/Objectives : Combine knowledge of scientific, regulatory, and business issues to enable Abbott Nutrition products/business activities to meet required legislation. Develop and supervise regulatory professionals.  Have department level influence and be generally recognized as an...