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 Affairs Sr. Manager or Associate Director who can develop and execute regulatory 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 strategies for client programs in various stages of development.
- Lead the preparation and submission of INDs, CTAs, NDAs/BLAs, etc. to the appropriate regulatory agencies for assigned projects.
- Serve as the primary liaison for FDA 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.
- Coordinate regulatory agency meeting activities including meeting requests, background packages, etc.
- Represent regulatory affairs on various cross-functional teams, including project teams, clinical development teams, manufacturing teams, etc.
- Maintain project budgets.
- 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 affairs for novel pharmaceuticals and/or biotherapeutics. Experience with medical devices or combination products is a plus.
- Experience with preparing IND submissions and background packages for regulatory meetings essential. Experience with successful NDA, sNDA and/or BLA filing preferred.
- Demonstrated knowledge of drug development process including knowledge of FDA and ICH guidelines and regulations for pharmaceuticals.
- Experience working directly with US health authorities.
- Strong knowledge of CTD and eCTD structure and excellent regulatory writing skills.
- Prior client-facing experience working at a CRO or Regulatory Consulting company desired. Experience in a small pharma company environment also preferred.
- Excellent organizational and project management skills.
- Outstanding written, verbal and interpersonal communications skills.
- Action oriented, customer focused, ability to manage workloads and 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.