Regulatory Sciences Associate Director
1 month ago
Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director to join our Global Regulatory Sciences team.
Job SummaryThe Regulatory Sciences Associate Director will be responsible for providing strategic guidance and input on current regulatory requirements and expectations for small molecule marketing applications, clinical trial applications, and lifecycle changes to marketed products. This role will also involve independently managing and prioritizing multiple complex projects, interfacing with Health Authorities for CMC submissions and CMC-related issues, and identifying, communicating, and proposing resolutions to routine and complex issues.
Responsibilities- Provide strategic guidance and input on current regulatory requirements and expectations for small molecule marketing applications, clinical trial applications, and lifecycle changes to marketed products.
- Independently manage and prioritize multiple complex projects.
- Interface with Health Authorities for CMC submissions and CMC-related issues.
- Identify, communicate, and propose resolutions to routine and complex issues.
- Interpret global regulations and guidance, identify regulatory opportunities and risks, and anticipate and communicate possible regulatory paradigm shifts.
- Participate in product fact-finding meetings, review and provide regulatory assessments on change controls, and prepare and manage CMC submissions for all global markets.
- Manage relationships with diverse teams, utilize electronic systems for dossier creation and tracking, and ensure thoroughness, completeness, and timeliness of submissions.
- Minimum BA/BS Degree.
- 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.
Bristol Myers Squibb offers a unique and inclusive work environment that promotes diversity in clinical trials. Our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.
We care about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
We will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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