Head of Regulatory Affairs

Posted 12 January 2023
Salary Up to US$0.00 per annum + DOE
LocationBoston
Job type Permanent
DisciplineLife Sciences
ReferenceBBBH138271_1673543733
Contact NameBria Gaber

Job description

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.

Requirements:

  • 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 bria.gaber@investigo-us.com or (646) 430-1191 for more information.