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Vice President of Regulatory Affairs

Employer
Barrington James
Location
Princeton, New Jersey
Salary
Competitive Base Salary with Benefits/Bonuses
Start date
6 Mar 2019
Closing date
5 Apr 2019

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Job Details

VP, Regulatory Affairs

The VP, Regulatory Affairs, is responsible for directing all regulatory activities from pre-clinical development through filing of marketing applications and post-approval activities in US. The role leads the efforts to obtain US approvals to market products and provides ongoing regulatory support for the products that will be commercialized. The role will be also responsible for managing interactions with the US FDA and for ensuring that regulatory documents are in compliance with US FDA regulations.

Job Description

  • Develops and implement regulatory strategies aimed at achieving marketing approvals and appropriate product labelling in the US and globally. Ensure cross functional alignment on regulatory plans and strategies
  • Responsible for the timely production and submission of regulatory documentation, including investigational new drug and marketing applications (IND, BLA etc) in compliance with US FDA requirements
  • Ensure compliance with US FDA/ICH regulations and guidelines related to pre-clinical and clinical, regulatory submissions, product launch, labelling and promotional activities
  • Serve as primary liaison with the US FDA, including overseeing the writing of pre-meeting briefing materials, leading the preparation for meetings with regulatory agencies and ensuring appropriate follow-up
  • Works closely with development teams, by providing guidance and technical input
  • Provides regulatory support to the business development activities to review potential licensing candidates

Requirements

  • Bachelor’s degree in scientific or life sciences discipline or related required, Advanced degree in scientific or life sciences discipline or related (e.g., PharmD, PhD, MD) strongly preferred.
  • Minimum of 15 years of progressive leadership in regulatory affairs in the biotech/pharmaceutical industry is required.
  • Prior working experience at US FDA is preferred
  • Extensive experience in non-clinical studies is preferred
  • Experience in successfully leading submission teams for US FDA Biologics License Application (BLA) and clinical trial applications (CTA) to clearance is required
  • Demonstrated track record for successful interactions with US FDA
  • Experience and/or knowledge of biologics and cell therapies is required.
  • Expert knowledge of US FDA and EMEA and other regulatory guidelines.
  • Candidate must be able to demonstrate strong relationship management, project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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