- Mumbai, Maharashtra, India +1 more
- Hybrid
- Full-time · Manager
- 8–12 years
Lead regulatory activities to support the development, registration and ongoing maintenance of pharmaceutical products across relevant markets.
Locations (2)
- Mumbai, Maharashtra, India
- Vadodara, Gujarat, India
Compensation
Competitive salary and benefits package.
Responsibilities
- Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
- Leads the preparation of core dossiers and submissions for global roll out.
- Authors, reviews and approves M1, M2 and M3 dossier sections as necessary, justification documents and Product Information.
- Ensures diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting.
- Interprets applicable regulations and guidelines for project team use and keeps team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.