Regulatory Affairs Director

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Operations
  3. United States
Boston, USA
Posting date: 05 Jun 2024

Regulatory Affairs Director - Permanent - Boston, MA

Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA.

Primary Responsibilities:

The successful candidate will work collaboratively with various teams to bring innovative and compliant approaches to the development and maintenance of our products. This role requires a strategic thinker who can continuously adapt regulatory strategies, provide regulatory input into product profiles, and ensure the flawless execution of global regulatory plans.

Skills & Requirements:

  • Advanced degree in a scientific discipline such as Pharmacy, Medicine, Chemistry, Biological Sciences.
  • Proven experience in drug development and managing complex worldwide products/projects within a relevant therapeutic area.
  • Excellent written and oral communication skills.
  • Solid project management skills.
  • Strong interpersonal and negotiation skills.
  • Strategic thinking and ability to derive creative solutions to regulatory problems.
  • Proven ability to lead change and communicate difficult messages effectively.

The Regulatory Affairs Director will:

  • Develop and implement regulatory strategies for assigned programs.
  • Provide regulatory input into target product profiles and Integrated Asset Strategic Plans.
  • Continuously evaluate and adapt development objectives and plans in line with new findings and regulatory requirements.
  • Define strategy for regulatory consultation and advocate for proposed strategies to senior leaders.
  • Identify potential risks and propose mitigation options.
  • Ensure flawless execution and implementation of global regulatory plans.
  • Conduct regulatory due diligence assessment on external opportunities.
  • Lead operational excellence initiatives within the Regulatory Affairs department.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or

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.