Associate Director, Global Regulatory Sciences - CMC

Bristol Myers Squibb • Princeton, NJ

10d • $164,020 - $198,759 • Hybrid

About The Position

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.
The GRS-CMC Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support BMS products regarding: Clinical trial applications; New marketing applications; HA responses and background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product Development and Supply (GPS) or Cell Therapy Development Operations (CTDO). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Requirements

• Minimum BA/BS Degree
• 8+ years Pharmaceutical industry experience – prefer knowledge of small molecules, biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy
• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicable
• Knowledge of pharmaceutical development, including advanced therapies and / or small molecules, biologic, and cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicable
• Inter-dependent partnering skills, team-oriented and ability to influence outcomes
• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to details
• Demonstrates ownership of results within (and beyond) area of responsibility
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved
• Looks for opportunities for continuous improvement
• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty
• Experience applying project management techniques within teams. Experience in effectively managing meetings
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
• Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate
• Demonstrated ability to coordinate global activities
• Ability to identify, communicate and resolve complex issues
• Prepare and manage filings and ensure thoroughness, accuracy and timeliness
• Ability to interpret global regulations and guidance
• Strong oral and written skills
• Proficient with electronic systems

Nice To Haves

• Expertise in the biological, cell therapy and/or small molecule modalities, drug development process and analytical methods, preferred as applicable

Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for small molecules, biologics, combination and device, cell therapy products development and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research
• Independently provide strategic guidance/input related to current regulatory requirements and expectation for marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
• Independently manage and prioritize multiple complex projects
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics
• Identify, communicate and propose resolutions to routine/complex issues
• Interpret global regulations and guidance. Identify regulatory opportunities and risks
• Provide strategic CMC regulatory expertise for development project teams
• Provide strategic input to development & GO teams to mitigate drug supply issues
• Interpret global regulations and guidance
• Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success
• Provide technical teams insight into regulatory health authority expectations
• Identify potential risks and help technical teams to formulate mitigation strategies to ensure regulatory success
• Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings
• Review and provide regulatory assessments on change controls
• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
• Utilize electronic systems for dossier creation and tracking
• 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
• Looks for opportunities for continuous improvement in processes and technology solutions
• Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impact on global regulatory strategy

Benefits

• 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
• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree