Head of, Vice President Regulatory Affairs
Greater Boston Area (Remote) - United States
Seeking a proven & polished leader with influence to Head up the Regulatory function for innovative biotech focusing on RNA-based therapeutics. The business is making great strides toward clinical development, and we are now covering all Executive hiring needs right now starting with Regulatory Affairs. Currently seeking a strong regulatory strategist to lead all regulatory activities, meetings, and major filings for the company.
This is a fast-paced, highly dynamic work environment, and this new hire will build and manage the regulatory team and ensure all activities are well-planned, compliant, and meet timelines with a drive to ensure the Company reaches goals and major milestones.
- Advanced degree in Life Sciences or Biology or equivalent required (Ph.D., Pharm.D.)
- 15 years in regulatory affairs within the biopharmaceutical industry or CRO settings.
- Experience in CNS-active or Oligonucleotide drugs.
- CMC Regulatory Affairs is highly desired.
- Proven experience in global regulatory submissions (EU, UK, US, and RoW), in particular, NDAs or MAAs, and their approvals required.
- Quality Management experience is highly desired.
- Extensive and comprehensive knowledge of the drug development process.
- Strong and successful FDA interactions and relations are required. Must be able to handle any FDA requests. Expertise and knowledge of FDA, EU, and ICH guidelines relating to CNS products.
- Successful track record of direct interactions/leading major global health authorities.
- Experience interfacing and responding to relevant global regulatory authorities specific to CNS products.
- Proven experience in global regulatory submissions (EU, UK, US, and RoW); INDs/CTAs, GMO submissions, briefing documents, PIPs/PSPs, orphan designations, and MAA/BLAs.
- Ability to think strategically and critically and evaluate risks to regulatory activities; ability to work effectively within a complex, business-critical, and high-profile development program.
If interested in learning more, please contact Bria Gaber at firstname.lastname@example.org or (646) 430-1191 for more information.