Bristol Myers Squibb Associate Director Biologics CMC in Devens, Massachusetts
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.
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologic products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions.
In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory and Safey Sciences (GRS) & Global Product Supply (GPS). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
Represent regulatory CMC on and/or lead matrix teams for biologic pipeline products 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 cell therapy 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 opportunity and risks.
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
Mange relationships with diverse teams
Utilize electronic systems for dossier creation and tracking.
Minimum BA/BS Degree (Masters or higher preferred) and 7-10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology products, including multi-disciplined experience, 6+ years CMC regulatory strategy (biologics experience preferred).
Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological compounds preferred.
Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the biologic drug development process and analytical methods, preferred.
Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
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
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.
Company: Bristol Myers Squibb
Req Number: R1531527-en-us-1
Updated: 2020-11-29 02:18:42.995 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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