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CMC Regulatory Affairs Director
2 months ago
We are seeking a highly skilled CMC Regulatory Affairs Director to join our team at Bristol-Myers Squibb. As a key member of our Global Regulatory Sciences (GRS) organization, you will be responsible for developing and implementing global regulatory strategies for CMC activities across all stages of a product's lifecycle.
Key Responsibilities- Develop and maintain strong working relationships with cross-functional teams, including regulatory CMC, product development, and manufacturing.
- Provide strategic guidance on current regulatory requirements and expectations for small molecule marketing applications, clinical trial applications, and lifecycle changes to marketed products.
- Manage and prioritize multiple complex projects, including regulatory assessments, submissions, and responses to Health Authority inquiries.
- Interface with 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 and complex issues related to CMC regulations and guidelines.
- Anticipate and communicate possible regulatory paradigm shifts and their impact on CMC strategies.
- Participate in product fact-finding meetings and provide regulatory expertise to support product development and lifecycle management.
- Review and provide regulatory assessments on change controls, including manufacturing changes and technical updates.
- Prepare and manage CMC submissions for all global markets, ensuring thoroughness, completeness, and timeliness.
- Minimum BA/BS Degree in a relevant field, such as life sciences, regulatory affairs, or a related field.
- 7-10+ years of experience in the pharmaceutical industry, with a minimum of 6 years of experience in CMC regulatory strategy.
- Knowledge of CMC regulatory requirements during development and post-approval, as well as 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 and maintain strong working relationships with 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 related to CMC regulations and guidelines.
- Prepare and manage filings and ensure thoroughness, accuracy, and timeliness.
- Ability to interpret global regulations and guidance.
Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our company is committed to innovation, diversity, and inclusion, and we strive to create a work environment that is inclusive, respectful, and supportive of all employees.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about regulatory affairs and want to join a dynamic team, please submit your application.
