Associate Director, Regulatory Affairs
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.
- 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 email@example.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.