Director, Regulatory CMC - Cell Therapy

Responsibilities

• Lead and oversee management of multiple development and life‑cycle management projects of varying priorities and complexities.
• Represent GRS‑CMC on cross‑functional teams, governance committees, and due diligence and in‑licensing projects.
• Represent BMS at Health Authority meetings and serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities.
• Develop and communicate strategic direction based on global regulatory guidelines and experience.
• Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness.
• Review CMC submissions from leaders for clarity of both strategic and technical content.
• Utilize electronic systems for dossier creation, review, and tracking.
• Manage and actively support growth and development of direct reports.
• Actively participate in leadership or department meetings.
• Anticipate and communicate possible regulatory paradigm shifts.
• Participate in product fact‑finding meetings and/or R&D forums representing GRS‑CMC.
• Support the preparation of CMC policies and procedures.
• Ensure regulatory compliance by monitoring and verifying timely and accurate data entry into the Regulatory Information Management system.

• Minimum BA/BS degree.
• At least 10 years of pharmaceutical or related experience, preference for multidiscipline experience, and 8+ years of regulatory CMC experience.
• Knowledge of CMC regulatory requirements for advanced therapies and/or cell therapy during development and post‑approval.
• Knowledge of pharmaceutical development, including advanced therapies and/or biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products.
• Ability to develop and maintain strong working relationships, lead multifunctional teams, prioritize multiple projects, and work independently.
• Ability to interact with CMC technical experts on process development and analytical issues.
• Understanding of scientific content and complexities; good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience leading cross‑functional teams, driving quality decision‑making, and organizing/ prioritizing tasks.
• Demonstrated ability to negotiate, influence others, and facilitate issue resolution and conflict management.
• Direct experience developing strategy and leading teams through interactions with health authorities; track record of issue resolutions with major regulatory authorities.
• Strong understanding of policy, laws, regulations, and guidelines as they apply to regulatory agencies globally.
• Good interpersonal skills and willingness to leverage strengths of the team in a cross‑functional environment.
• Experience communicating regulatory strategy, issues, and risks in written and verbal formats to senior leadership and governing bodies.
• Demonstrated ownership of results within and beyond area of responsibility.
• Experience as a member of the CMC team, GRTs, project working groups, or comparable experience.
• Experience developing strategy for product partnership (out‑licensing, divestiture, co‑development, in‑licensing, acquisitions).
• Ability to broadly represent department functions on project teams in a matrix organization.
• Prior management experience preferred.
• Proficient with electronic systems.
• Travel up to 5% of the time.

Madison – Giralda – NJ – US: $199,950 – $242,297. The starting compensation range is for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final individual compensation will be decided based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work‑life benefits:
  Paid Time Off, flexible time off (unlimited for exempt employees with manager approval), 11 paid national holidays (except for certain employees), 160‑hour annual paid vacation for new hires (non‑exempt, hourly), unlimited paid sick time, paid volunteer days, summer hours flexibility, leaves of absence, and an annual Global Shutdown.

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