Associate Director - GRS CMC Cell Therapy

Workowon; Hyderabad; On-site; INR 14,286,000 - 20,000,000; Full time

Benefits offered by this job

Wellness programs

Job summary

Bristol Myers Squibb is seeking an Associate Director for GRS-CMC cell therapy to provide regulatory expertise across the product lifecycle and to lead a team of CMC regulatory professionals.

You will set strategic direction, build a high‑performing team, oversee CMC submissions, and represent the function in cross‑functional and governance settings while engaging with Health Authorities as needed.

Qualifications

• 8+ years pharmaceutical industry experience – biotechnology or cell therapy preferred.
• 5+ years in CMC regulatory strategy.
• Prior people management or team leadership experience preferred; coaching and mentoring.
• Knowledge of CMC regulatory requirements for advanced therapies, biologics, and cell therapy.
• Experience communicating regulatory strategy, issues, and risks to senior leadership and governing bodies.

Responsibilities

• Set priorities for the Team aligned to GRS-CMC and company strategy, and communicate strategic direction.
• Build and lead a diverse, high-performing Team through recruitment, engagement, coaching, and mentoring.
• Manage and actively support growth and development of direct reports and team members.
• Drive continuous improvement of processes and technology within the team.
• Oversee preparation and review of CMC submissions for clarity, thoroughness, and timeliness.
• Represent GRS-CMC on cross-functional teams and governance committees; serve as a credible spokesperson.
• Act as SME on regulatory policy topics related to GRS priorities and engage externally.
• Interface with Health Authorities for CMC submissions under supervisor guidance.

Skills

CMC Regulatory Strategy

Cell Therapy

Regulatory Affairs

People Management

Pharmaceutical Development

Education

BA/BS Degree

Job description

Job Description

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

• 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

Benefits

• Wellness programs