Associate Director, Global Regulatory CMC Biologics
- Summit, NJ
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Responsibilities will include, but are not limited to, the following:
- Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings
- Lead the preparation and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.
- Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required.
- Responsible for the management of CMC activities related to specific developmental or commercial compounds.
- Responsible for the regulatory evaluation of CMC change controls.
- Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.
- Take a leadership role in the CMC development/commercial teams.
- Maintain knowledge of global regulatory environment, regulations and procedures.
- BS/BA degree in Scientific Discipline (Masters or higher preferred) with a minimum of 7 years in the pharmaceutical industry, with a minimum of 5 years CMC regulatory (biologics preferred) experience.
- Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
- Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.
- Combination product experience preferred (Prefilled drug delivery systems)
- Thorough knowledge of FDA, EMEA and ICH guidelines.
- Knowledge of rest of world pre- and post-approval guidelines
- Have a solution-oriented approach to problem solving
- Expertise in the biologic drug development process and post approval activities
- Ability to work on complex projects and within cross-functional teams with minimal supervision
- Prior supervisor or project management experience
- Experience with global CMC regulations for biological compounds.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
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