This client is a growing life science consulting firm which provides regulatory and development support to small, emerging pharmaceutical and biotech companies. They are seeking a Regulatory CMC Sr. Manager or Associate Director who can develop and execute regulatory CMC strategies for client programs in development and work directly with the FDA. This company offers a competitive salary, a comprehensive benefits package, and the ability to work remotely from home.
- Develop and lead US regulatory CMC strategies for client programs in various stages of development.
- Lead the preparation and submission of CMC sections INDs, CTAs, NDAs/BLAs, etc. to the appropriate regulatory agencies for assigned projects.
- Serve as the primary liaison for FDA regarding CMC issues on assigned projects. Respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
- Interface directly with the firm’s clients.
- Ensure that all regulatory documents have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
- Represent regulatory CMC on various cross-functional teams, including project teams, clinical development teams, manufacturing teams, etc.
- Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
Knowledge and Skills:
- BA/BS degree in a scientific field; advanced degree preferred (MS, PharmD, PhD).
- At least five years of experience in regulatory CMC for pharmaceuticals and/or biotherapeutics. Experience with medical devices or combination products is a plus.
- Experience with preparing CMC sections for IND, NDA, sNDA and/or BLA filings.
- Demonstrated knowledge of drug development process including knowledge of FDA and ICH guidelines and regulations for pharmaceuticals.
- Experience working directly with US health authorities. Prior hands on experience of FDA CMC regulatory submissions is essential.
- Strong knowledge of CTD and eCTD structure and excellent regulatory writing skills.
- Prior client-facing experience working at a CRO or Regulatory Consulting company highly desired.
- Excellent organizational and project management skills.
- Outstanding written, verbal and interpersonal communications skills.
- Action oriented, customer focused, collaborative and able to set priorities.
- Ability to work independently with minimal oversight.
NOTE: Our client cannot support a visa transfer or visa sponsorship. All candidates must be authorized to work in the United States.