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AD/Director, Regulatory Affairs CMC Strategy

  • Job type: Permanent
  • Location: New York
  • Salary: $170000 - $220000 per annum
  • Job reference: JEAO31418956
  • Sector: EPM Scientific, Regulatory
  • Date posted: 14/03/2018
Director/Sr. Director, Regulatory CMC Strategy required for rapidly expanding Biotech focused on Gene Therapy
  • Director/Sr. Director, Regulatory CMC | Gene Therapy
  • Greater NYC Area
  • excellent base + excellent benefits + equity incentives
A rapidly growing Biotech, which focuses on establishing curative gene therapy products to cure undertreated rare diseases, is actively looking to speak with a hands-on Regulatory CMC expert to proactively manage multiple Regulatory CMC projects and spearhead the companies gene therapy program.

The successful candidate will act as the key regulatory strategist for CMC projects and would be the main point of contact for the FDA and Global Health Authorities. This organization embodies a passionate learning environment and places strong emphasis an employees' aspirations to help the company grow.

Requirements:
  • Spearhead global Regulatory-CMC strategy for Gene Therapy programs form Clinical Development to Licensure
  • Execute submission activities to FDA and global Health Authorities (IND, IMPD, BLAs, MAAs).
  • Oversee the preparation and review of CMC submission documents, registration dossiers, etc.
 Qualifications:
  • BS degree in Life Sciences, advanced degree preferred
  • 5+ years of regulatory CMC/ 4-5 years viral vector gene therapy experience (AAV, LLV, etc.)
  • Experience interfacing and responding to relevant global regulatory authorities for gene therapy products 
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