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.
