Reports to: Head of Regulatory Affairs
Location: Greater Boston Area
Email: resume@bpsearches.com
Position Summary
Bio-Pharma Searches, Inc. is working closely with a small biotech to assist them in finding several top-level executives to join their Regulatory Affairs team. One of which is a Director (or Assoc. Dir), CMC Submissions & Regulatory Affairs that will be based at their Cambridge, MA site. The individual in this role, you 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. This is a smaller company with a bright future and this couldn’t be a better time to join the team!
Responsibilities
- Provide leadership for regulatory CMC aspects of product development projects
- Lead and drive all CMC submission activities (planning,
- Review documents for submission-readiness,to ensure that all submissions conform to health authority guidelines
- Develop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
- Lead 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
Minimum Qualifications
- BA/BS degree in a scientific/engineering discipline
- 10+ years’ experience in the Pharmaceutical industry
- 5+ years’ 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 Qualifications
- M.S. degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
- 15 years of experience in regulatory in the pharmaceutical/biotech industry
- 8+ years’ experience in Regulatory CMC
Competencies
- Leading Change
- Respect for People
- Collaboration
- Communication
- People Developer
- Strategic Thinking
- Operational Execution
- Creative Problem-Solving
- Decision Making