CMC Regulatory Associate Director Biologics
2 weeks ago
Work with Us
At Bristol Myers Squibb, we're committed to transforming patients' lives through science. As a key member of our team, you'll play a vital role in shaping the future of healthcare. Our work is challenging, meaningful, and life-changing – and so is your career.
The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products. This role serves as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.
Key Responsibilities
- Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research
- Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule 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 oversight 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
- Manage relationships with diverse teams
- Utilize electronic systems for dossier creation and tracking.
Requirements
- 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy
- Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products.
- Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods.
- 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.
About Us
We're committed to creating a culture that promotes diversity, inclusion, and belonging. Our values of passion, innovation, urgency, accountability, inclusion, and integrity guide our work and inspire us to make a meaningful impact. Join our team and be part of a community that shares your passion for science and your commitment to transforming patients' lives.
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