First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP, Officer /Associate, Project Manager

Location: United States

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.

#LI-FG1