Associate Director, Regulatory Affairs

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Officer /Associate, Project Manager
  3. United States
King of Prussia, USA
Posting date: 16 Mar 2021
RA.FG.36301

Proclinical is currently recruiting for an Associate Director of Regulatory Affairs for a global gene therapy program located in King of Prussia, PA. As the Associate Director, you will manage the preparation of high-quality regulatory documents and dossiers including, but not limited to CTA/IND, FDA briefing packages, scientific advice briefing packages, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings.

Job Responsibilities:

  • Contribute to project teams and sub-teams for the company's gene therapy and medical device pipeline.
  • Provide strategic and tactical input to project and regulatory sub-teams in all aspects of regulatory affairs.
  • Manage external vendors (consultants, CROs and regulatory authorities)
  • Contribute to the growth of the regulatory affairs function, supporting GxP compliance and inspections.
  • Remain expert and up to date on global regulatory requirements for ATMPs.
  • Keep abreast of relevant regulatory intelligence and ensuring this is effectively disseminated within the organization.
  • Assist with training of staff in regulatory matters as required.

Skills and Requirements:

  • BA/BS in the life sciences or equivalent work experience is required. Advanced degree advantageous.
  • 7+ years' experience in regulatory affairs, with experience in biotechnology/biologicals/drug-device combination products-- development gained in industry or service provider environments.
  • Experience of European and US regulatory affairs e.g. CTA/IND/MAA/BLA/BLA combination product, preparation and submissions. Experience with medical devices and in vitro diagnostics a plus.
  • Knowledge and understanding of US, EU and ICH guidelines and experience of working to GxP. Understanding of medical device and companion diagnostic regulations is a bonus.
  • Experience of planning meetings with the FDA, the EMA and European national regulatory authorities.
  • Experience in creation and execution of effective regulatory strategies and developing solutions for solving regulatory problems.
  • Experience in interactions and submissions with regulatory agencies including EMA, European national agencies and the FDA and vendors/consultants.
  • Experience in working with ATMP's particularly gene therapy and medical devices in Europe and USA is desirable.
  • Experience in ophthalmology drug / device development.
  • Work effectively and collaboratively in a matrix environment, utilizing excellent interpersonal skills including strong oral and excellent written communication skills to get results.
  • Excellent oral and written communication, interpersonal, analytical, and computer skills.
  • Is proactive, a fast-learner, is flexible and adept at working in a fast-paced, changing environment with strong problem solving and analytical skills.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or f.gbadamosi@proclinical.com.

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.

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