About The Job

Bristol Myers Squibb is seeking an Associate Director for GRS-CMC cell therapy to provide regulatory expertise related to CMC activities through all stages of a product's lifecycle and lead a team of CMC regulatory professionals.

Key Responsibilities

- Provide direction and set priorities for the Team, aligned to GRS-CMC and company strategy, and communicate strategic direction based on global regulatory guidelines and experience.
- Build and lead a diverse, high-performing Team through targeted recruitment, engagement, coaching, and mentoring.
- Manage and actively support the growth and development of direct reports and/or Team members.
- Proactively manage the Team to take advantage of unplanned opportunities and overcome unforeseen obstacles, with a focus on continuous improvement of processes and technology.
- Oversee the preparation of CMC submissions across the Team’s projects and review submissions prepared by Team members for clarity of both strategic and technical content, thoroughness, completeness, and timeliness.
- Represent GRS-CMC on cross-functional teams and, as delegated, on governance committees; serve as a credible, respected spokesperson in discussions with key stakeholders.




- Act as SME on assigned or agreed regulatory policy topics related to GRS priorities and engage externally to advance key regulatory positions.
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics.

Requirements

Requirements

- Minimum BA/BS Degree
- 8+ years Pharmaceutical industry experience – prefer knowledge of biotechnology or cell therapy products, including multi-disciplined experience, with 5+ years in CMC regulatory strategy.
- Prior people management or team leadership experience preferred; experience coaching, mentoring, and developing team members.

- Knowledge of CMC regulatory requirements for advanced therapies, biologics, and cell therapy during development and post-approval as applicable.
- Knowledge of pharmaceutical development, including advanced therapies, biologic, and cell therapy upstream and downstream processes, analytical methods, and biologic/device combination.
- Experience communicating regulatory strategy, issues, and risks, in written and verbal format, to regulatory senior leadership and other governing bodies.

Skills CMC Regulatory StrategyCell TherapyRegulatory AffairsPeople ManagementPharmaceutical Development

Advantages

- Wellness programs

📌 Associate Director - GRS CMC Cell Therapy (Hyderabad)
🏢 Workowon
📍 Hyderabad