Director, Regulatory CMC - Cell Therapy

Bristol Myers Squibb•Bethesda, MD

3d•Remote

About The Position

At Bristol Myers Squibb, our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The GRS-CMC Director is responsible for overseeing 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 /in-licensing projects. Represent BMS at Health Authority meetings. 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. Seeks opportunities for external regulatory engagement for themselves and/or members of their team.

Requirements

Minimum BA/BS Degree
Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience
Knowledge of CMC regulatory requirements for advanced therapies and/or and 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
Direct experience in developing strategy and leading teams through interactions with health authorities, track records of issue resolutions with main regulatory authorities; 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
Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment; looks for opportunities for continuous improvement
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
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
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, and acquisitions)
Ability to broadly represent department functions on project team in a matrix organization
Seeks multiple perspectives and listens openly to others’ points of views
Proficient with electronic systems

Nice To Haves

Prior management experience preferred

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
Actively participates 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: 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

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day