VP of Global Regulatory Affairs

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. United States
New York, USA
Posting date: 23 Oct 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a VP of Global Regulatory Affairs to join a biotech organisation. This role is on a permanent basis and is located in the US.


  • Accountable for docking with HQ's regulatory affairs team to assist with international registration applications and guide a team of up to 20 personnel.
  • Form a regulatory consultant team, guaranteeing consultation and resolution of challenging problems in a timely manner.
  • You will be accountable for product registration methods and contribute to formulating product development methods.
  • Contribute to due diligence and deliberations throughout the procedure of in/out-licensing.
  • Keep up to date on regulatory guidelines and alterations, discussing the impact to the team.
  • The ideal candidate will alter methods when required, examine product development risks and implement them to product development.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level in a biologic, medicine, pharmacy or similar discipline.
  • Demonstrable regulatory experience within a biotech or pharmaceutical organisation with a background in successful investigational archiving and approvals of marketing applications from IND to BLA.
  • Presentation and communication skills both verbally and in writing.
  • Fluency in the English language with knowledge in Chinese would be advantageous.
  • Keen to be based in the US and travel for business needs internationally.
  • A background in registration methods and international product development.
  • Expertise on FDA CDER or CBER divisions.
  • Know-how of new drug development guidelines and FDA, EMA regulations, specifically but not limited to clinical development.
  • Knowledge of the drug development procedure, GCPs and principles in clinical trial performance.
  • Familiarity with regulatory proposals and IND/BLA proposals, with comprehension of their context and content.

If you are having difficulty in applying or if you have any questions, please contact Evelyn Li at +49 69 509 556 03.

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.