Director, Regulatory CMC - Cell Therapy

About the role

The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. They represent GRS-CMC on cross-functional teams, governance committees, and due diligence/in-licensing projects. They represent BMS at Health Authority meetings. They serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. They develop and communicate strategic direction based on global regulatory guidelines and experience.

• 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 submissions from CMC Leads 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
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings and/or R&D forums representing GRS-CMC
• Manage relationships with diverse teams
• Support the preparation of CMC policies and procedures
• Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes

Responsibilities

Duties/Responsibilities

• 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 submissions from CMC Leads 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
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings and/or R&D forums representing GRS-CMC
• Manage relationships with diverse teams
• Support the preparation of CMC policies and procedures
• Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes

Qualifications

• Minimum BA/BS Degree
• Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience

Key Competencies

• Knowledge of CMC regulatory requirements for advanced therapies and/or cell therapy during development and post-approval as applicable
• Knowledge of pharmaceutical development, including advanced therapies and/or, biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products as applicable
• Ability to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
• Ability to interact with CMC technical experts regarding technical issues such as those related to process development and analytical
• Understanding of scientific content and complexities and good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration
• Experience leading cross-functional teams, demonstrated ability to drive quality decision-making and ability to organize / prioritize tasks
• Demonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict management
• Demonstrated ability to break down complex, scientific content into logical components
• Strong understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty and sets clear and high expectations and holds self and others accountable for decisions and results achieved. Demonstrates ownership of results within (and beyond) area of responsibility
• Ability to broadly represent department functions on project team in a matrix organization
• Sets multiple perspectives and listens openly to others’ points of views
• Prior management experience preferred
• Proficient with electronic systems

Benefits

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as 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 Include Paid Time Off