Associate Director, Global Regulatory Sciences CMC

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. 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.

Position Summary

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products 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 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.

Candidates with prior experience working with small molecules will be prioritized for this role.

Duties/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 teamsinsight 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 inproduct 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

Qualifications

• 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
• Expertise in the biological cell therapy and/or small molecule modalities drug development process and analytical methods preferred 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
• This position may require up to 5% of travel

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

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