Sr./Manager, CMC Regulatory Affairs
The Sr./Manager, CMC Regulatory Affairs will be based at the Cambridge and Norwood, MA sites and will be responsible for preparing 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 all regulatory activities to support high quality CMC sections of regulatory documentation.
- Develop 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.
- Develop 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.
- BA/BS degree in a scientific/engineering discipline
- 8+ years of experience in the Pharmaceutical industry
- 4+ years of experience in Regulatory CMC, including DMF/ASMF submissions
- Strong knowledge of current US and EU regulations and cGMP
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Preferred: M.S. degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
- Preferred: 12 years of experience in regulatory in the pharmaceutical/biotech industry
- Preferred: 6+ years of experience in Regulatory CMC
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.