Director EU Regulatory Affairs
Proclinical is currently recruiting a Director of EU Regulatory Affairs for a pharmaceutical company located in Cranbury, NJ. Successful candidate will lead the development and implementation of the EU regulatory strategy for their gene therapy programs in accordance with EU regulations and through collaboration with external partners, internal cross-functional teams, and global health authorities.
- Lead the development and implementation of the EU regulatory strategy across the company's gene therapy pipeline, in coordination with the overall global regulatory strategy to support efficient development and approval of their gene therapy products.
- Own the development and timely submission of high-quality regulatory documents to EU health authorities.
- Serve as the primary point of contact with EU regulatory agencies, including leading formal and informal meetings with relevant agencies and responding to health authority inquiries.
- Ensure regulatory compliance, i.e., advice received from and commitments made to EU health authorities are fully implemented in the company's development programs.
- Stay abreast of, analyzes, and effectively communicates relevant changes to the EU regulatory landscape to management.
- Guide the implementation of any relevant EU regulatory changes to programs.
- Collaborate with and manages regulatory consultants and other vendors as required.
Skills and Requirements:
- BA/BS/University degree in Life/Health Sciences required; PharmD, MD, PhD or JD preferred.
- 6-8 years of EU regulatory experience with a premarket focus.
- Strong scientific background. Cell and gene therapy experience strongly preferred.
- Proficient with other international regulations, including ICH guidelines.
- Strong leader but also strong team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solve.
- Ability to thrive in a fast-paced environment.
- Strong writing skills is a must, including ability to author documents.
- Ability to communicate effectively.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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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