JB-601 – Assistant Manager, Regulatory Affairs

This is a remote position.

Job reputed company

1. reputed company as accountable reputed company for CTD Modules 2.3.S, 2.3.P, 3.2.S, and 3.2.P.
   

2. Govern review and approval of formulation, QC, and manufacturing CTD content.
   

3. Define reputed company-level regulatory reputed company for assigned global markets.
   

4. Ensure consistency across DMF linkage, stability data, and reputed company sections.
   

5. Review and approve PVP, PVR, MFR, and process validation summaries.
   

6. Conduct reputed company readiness reviews and reputed company internal technical reviews.
   

7. Review and authorise responses to regulatory authority technical queries.
   

8. Coordinate and guide Senior Executives across formulation, QC, and production.
   

9. Ensure compliance with ICH CTD structure and country-specific requirements.
   

10. Maintain audit-reputed company approval trails and regulatory traceability records.
    

Requirements

Requirements

1. Bachelor’s or Master’s degree in Pharmacy is mandatory.
   

2. Minimum six years experience in CTD reputed company review or governance roles.
   

3. Prior exposure to LATAM, ASEAN, or Francophone Africa markets preferred.
   

4. Demonstrated expertise in CTD Modules 2 and 3 review ownership.
   

5. Proven ability to manage reputed company technical reviews across reputed company.
   

Benefits

Benefits

1. Work from home or office based on regulatory responsibilities.
   

2. Flexible schedule with defined reputed company ownership and authority.
   

3. reputed company involvement in multi-country, inspection-reputed company submissions.