Great job opportunity as Require Regulatory Affairs Manager at Sun Pharmaceutical- Apply before  30th June 2024

Sun Pharma
  • Full Time
  • Halol

Website Sun Pharmaceutical

About Sun Pharmaceutical

It is an Indian multinational pharmaceutical company headquartered in Mumbai, India. It is one of the largest pharmaceutical companies in the world by market capitalization and revenue. Sun Pharma manufactures and markets a wide range of pharmaceutical formulations and active pharmaceutical ingredients (APIs) in various therapeutic areas including cardiology, psychiatry, neurology, gastroenterology, and oncology, among others. The company has a global presence with operations in over 150 countries and a strong focus on research and development to introduce innovative and affordable healthcare solutions.

Job Opportunity: Manager – Regulatory Affairs (2 Positions)

Job Description

1. Document Compilation and Filing

  • Oversee the compilation of documents for new product filings, re-registration/renewals, and sample requirements from plant dossier submissions.

2. Regulatory Action Plan and Submission Monitoring

  • Participate in action plan discussions for regulatory queries and monitor the submission of data/documents from the plant.

3. Coordination with Cross-Functional Teams

  • Collaborate with CRA, ADD, FDD, MSTG, PMO, Plant teams, and other CFT members to fulfill regulatory requirements related to registration, re-registration, queries, and variation filing.

4. Product Life Cycle Management

  • Actively participate in change control committee meetings, discuss with stakeholders, and decide on the final variation category in consultation with CRA, Country RA, and customers if needed.

5. Variation Management Activities

  • Track variation filings, approvals, and inform the plant about the implementation of changes.

6. Business Continuity Support

  • Assist the plant in maintaining business continuity by filing variations as necessary.

7. Regulatory Approvals Monitoring

  • Oversee the distribution of regulatory approvals and commitment details to the plant team for US, OAM, and emerging markets.

8. Launch Discussions Participation

  • Engage in launch discussions with the plant CFT, business team, and CRA to identify gaps and develop mitigation plans.

9. Regulatory Strategies and Guidelines Circulation

  • Distribute regulatory strategies and guidelines as required.

10. Regulatory Inspection Support

  • Provide support to the plant during regulatory inspections.

11. Product Permissions and Test Licenses Monitoring

  • Monitor product permissions, test licenses, and archival activities for local FDA.

Candidate Profile

Internal Interactions: Production, Quality, MSTG, NPQC, CRA, FDD, ADD, PDD

External Interactions: Customers, Country RA

Additional Information

Experience: 10-12 Years

Qualification: M.Sc., B.Pharm, M.Pharm

Location: Halol

Industry Type: Pharma, Healthcare, Clinical Research

Functional Area: Regulatory Affairs

End Date: 30th June 2024

Join our team and contribute to the success of India’s leading pharmaceutical company by ensuring regulatory compliance and excellence. Apply now to become a vital part of our mission to provide high-quality healthcare solutions globally.

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