U.S. Regulatory Lead

Highly Competitive Salary
  1. Permanent
  2. Labelling & Artwork, Publishing & Submissions, Operations
  3. United States
Cambridge, USA
Posting date: 16 Jul 2020
RA.ZH.30591

Proclinical is currently recruiting for a U.S. Regulatory Lead with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

  • Core member of the RPT collaboratively working with the team to represent the US Business and weave US strategies into global strategies as they are developed.
  • US participant on Product Cross Functional Team as appropriate.
  • Key contact for FDA on product(s) and with direct FDA interaction. Ensures communications from FDA are properly communicated to the business after assessing the feedback and outlining next steps.
  • Key contact for internal research, development and business partners on product(s).
  • Drive US product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling. Partners with US Commercial and Ad Promo Team.
  • Responsible for IND, NDA, and BLA submissions to FDA in partners with Regulatory Operations.
  • Responsible for product labeling, working with the GRL to ensure core label changes are appropriately conveyed in US product labeling.
  • Regulatory representative on due diligence assessments of new business opportunities as required.
  • Provide mentorship to junior regulatory staff.

Skills and Requirements:

  • 8+ years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs.
  • Delivery of at least one major application (NDA or BLA) or extensive experience with neurology late stage development/marketed products.
  • Great leadership skills with high emotional intelligence.
  • Must be a great team player with strong verbal and written communication skills.

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-ZH1

close