Affairs Director (EU)
Responsible to: VP, Global Regulatory Affairs
Responsible for: No
A specialist Cell and Gene Therapy organisation at the forefront of products for clinical use are currently looking for a Regulatory Affairs Director to join the team at a very exciting time in the company’s expansion. You will be working closely with the Regulatory VP to apply innovative technologies with the aim of improving the treatment of cancer. You will assist with development and execution of regulatory strategies for Cell Medica products and ensure regulatory submissions in the EU and other designated territories, are granted and maintained in support of the Company’s business objectives. You will play an important role in coordinating regulatory meetings and communications with European competent authorities.
â€¢ A hands on approach to the development of regulatory strategy for new products
â€¢ The preparation and coordination of regulatory authority meetings providing regulatory expertise
â€¢ Proactive in the compilation and submitting of CTAs, ODDs and MAAs
â€¢ Provide strategic regulatory input for ATMP development
â€¢ Provide expertise in EU Regulatory Affairs and provide support as required, including providing guidance to internal departments of development teams
â€¢ Review all regulatory agency compliance materials to guarantee accuracy
â€¢ Attend and provide regulatory expertise at regulatory authority meetings
â€¢ Provide expert regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
â€¢ Liaise with external collaborators and manage external resources such as CROs
â€¢ Contribute to the establishment of the global regulatory function and organisation of company regulatory data
Education and Experience
â€¢ Relevant Scientific qualification (post graduate would be highly beneficial)
â€¢ Extensive experience working in EU regulatory affairs within industry
â€¢ Experience within ATMP development
â€¢ Experience within Immunology, Oncology and ideally hand on experience within Cell and Gene therapy
â€¢ Experience working across early phase and late stage development
â€¢ Working within new product development for biotechnology products
â€¢ Previous experience and success within regulatory authority meetings
â€¢ Excellent writing skills and proficiency with Microsoft Word and Adobe Acrobat.
â€¢ Thorough understanding of EMA and national European regulation
â€¢ Management of external resources and liaison with external collaborators
â€¢ Self motivated and able to work independently
â€¢ Ability to think creatively in order to achieve solutions to potential regulatory roadblocks
â€¢ Good communicator with ability to interact successfully across disciplines and levels
â€¢ Professionally credible and authoritative
The personal data you provide in your application and as part of the recruitment process will only be held and processed for the purpose of the selection process and in connection with any subsequent employment or placement, unless otherwise indicated. Your data will be retained only for as long as is permitted by UK legislation and then destroyed.
Unsuccessful applicant data will be held within the recruitment system for a period of no longer than two years before being deleted.
Please be aware that Cell Medica uses a third party supplier to hold the information you submit. The third party company complies with General Data Protection Regulation and Cell Medica’s security policy and therefore will not share your data with anyone other than Cell Medica. In the event of your application resulting in an offer and your acceptance of a position at Cell Medica, your personal information will be transferred to our employee database held by the same third party supplier and also transferred to Cell Medica’s electronic Personnel files.