Director – Global Regulatory CMC – Rare Diseases
| Company | Moderna |
|---|---|
| Location | Cambridge, MA, USA, Norwood, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in a scientific/engineering discipline
- Minimum of 12 years of experience in the pharmaceutical/biotech industry
- Minimum of 8 years of experience in Regulatory CMC
- Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
- Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
- Prior management experience required
- Excellent interpersonal skills for internal and external negotiation and influence
- Exceptional written and oral communication skills
Responsibilities
- Develop/implement 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
- Lead 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
- Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls
- Provide interpretation of regulatory guidance documents, regulations, and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
- Potentially has oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)
Preferred Qualifications
- MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable
- 15+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
- 8+ years of experience in Biologics focused Regulatory CMC