Director, Global Regulatory Affairs

Posted 14 November 2019
Salary Up to US$185000.00 per annum + negotiable
Location
Job type Permanent
ReferenceBBBH91424_1573741854
Contact NameBria Gaber

Job description

Director, Global Regulatory Affairs

New York - United States

We are seeking candidates with strong global Regulatory Affairs experience to serve as the Global Regulatory Team Lead for a Phase III program and its anticipated filings (NDA/MAA). This opportunity is best suited for a hands-on and creative regulatory strategist with the skills to support actions required to advance the new program to registration. This Director of Regulatory Affairs will be a strategic leader within the department, reporting directly to the Head. This individual will function as a key member of the group and regulatory lead, influencing the development strategy and regulatory plans for the program. This Director of Regulatory Affairs will be responsible for direct interactions with global health authorities as the primary contact for the assigned programs to influence development strategy and to defend regulatory position with the health authorities.

Seeking a strong global leader and experienced director of regulatory affairs with the following qualifications:

  • B.S. or M.S. degree in life sciences with a minimum of 7+ years of relevant pharma/biotech industry experience within regulatory affairs; Advanced degree (PhD, PharmD) and/or RAPS certification is a plus
  • CNS therapeutic area and/or Rare Disease drug development experience is highly preferred
  • Prepared successful IND submissions, and approval/post-approval management of NDAs in the US; filing experience in other ICH regions is preferred
  • Strong knowledge of pertinent regulations in ICH regions and solid working experience of GCPs and GLPs
  • Managerial experience with leading regulatory strategy for high acuity and life-threatening disorders
  • Strong leadership and project management skills, including proven cross-functional communication, negotiation and conflict management skills
  • Successful track record of direct interactions with global health authorities is required
  • Travel expectations: Approximately 10% domestic and international travel for meetings/conferences with health authorities

If interested in learning more, please contact me at bria.gaber@investigo-us.com or 646.430.1191 for more information.