Senior Manager, CMC Regulatory Affairs
About The Position
The candidate in this role will be based at the Norwood MA site and will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients.
Requirements
- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
- 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 5+ years of experience in focused Regulatory CMC, preferably Biologics based
- Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)
- Strong knowledge of current US, EU and ROW regulations
- Strong knowledge of cGMP
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
Responsibilities
- Support effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
- Provide guidance for regulatory CMC aspects of product development projects
- Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
- Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
- Support regulatory processes and procedures to support CMC components of regulatory submissions
- Support the creation and maintenance of CMC submission templates
- Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
- Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
Benefits
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Senior
