Job Reference: J563141
Updated On: 19/10/2018
Status: Now Interviewing
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Role OverviewA fantastic opportunity for an experienced Senior Regulatory Affairs Manager has become available within a developing Cell and Gene Therapy company based just outside of Greater London. You will report to the Director of Regulatory Affairs and will personally develop and implement regulatory strategy for current product development, Clinical Trail submission and for Marketing Authorisation Submission. This is a fantastic opportunity for Regulatory Affairs professionals that wants to join a developing Advanced Therapies company and play an integral part in the registration of novel therapeutics.
Key Duties and ResponsibilitiesYour duties as the Senior Manager of Regulatory Affairs with a focus on ATMP will be varied however the key duties and responsibilities are as follows:
1. Drive Regulatory strategy and operations in relation to product development and registration.
2. Prepare high quality regulatory documentation including but not limited to CTA / IND / IMPD, Scientific Advice briefing packages, PRIME applications, PIP / PSP, MAA / BLA as well as responses to questions by relevant agencies.
3. Liaise with Regulatory agencies including the MHRA, EMA and FDA for EU and US markets where you will act as the point of contact for submission of relevant documentation
4. You will maintain and up to date knowledge of Global Regulatory requirements for ATMP products including Clinical and CMC aspects.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Manager - ATMP we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline (e.e Biology, Biochemistry, Biotechnology, Pharmacology etc.) with hands on experience in a Regulatory Affairs environment within a Biotechnology / Biologics and / or Rare disease industry.
2. Proven industry experience in a Regulatory Affairs setting where you are contributing to the early development of products through to the preparation of CTA / IND strategy and submission to MAA / BLA filings to EU and US markets.
3. Ability to plan and lead meetings with the FDA, EMA and European national regulatory authorities.
Key Words: Cell Therapy | Gene Therapy | Cell and Gene Therapy | ATMP | Biologics | Regulatory Affairs | IMPD | IND | CTD | MAA | EU | FDA | PIP | PRIME | Orphan Drug | Strategy | Lead | Management | Project Management | Biopharmaceutical | Pharmaceutical | Senior Manager
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