R&D Head Sr. GMAVP
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About company - Mid size Indian pharma company with multiple manufcaturing sites
Key Responsibilities:
- Define and execute R&D strategy aligned with business portfolio and regulatory goals.
- Lead Process R&D and Analytical R&D functions ensuring timely development scale-up and tech transfer.
- Oversee development of robust safe and economical API processes and control strategies.
- Ensure compliance with ICH cGMP EHS and global regulatory requirements.
- Review and approve DMF/ANDA/CEP technical content and responses to regulatory queries.
- Act as primary SME during regulatory inspections customer audits and due diligences.
- Drive cross-functional collaboration with Manufacturing QA QC EHS Supply Chain and Business Development.
- Lead investigation and resolution of critical deviations OOS/OOT and process or analytical failures.
- Build and develop high-performing R&D teams; manage budgets resources and capability development.
- Drive innovation cost reduction yield improvement and lifecycle management of commercial products.
Qualification & Experience (Typical)
- Ph.D./. in Chemistry or Chemical Engineering
- 18–25 years experience in API R&D with strong regulatory exposure
- Proven leadership of multi-site or multi-function R&D teams
