Associate Director, Global Regulatory Sciences - CMC

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary 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. 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 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 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 If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Madison - Giralda - NJ - US: $164,020 - $198,759 New Brunswick - NJ - US: $164,020 - $198,759 Princeton - NJ - US: $164,020 - $198,759 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, an