Job Reference: J5631279
Updated On: 09/04/2019
Status: Now Interviewing
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Role OverviewA fantastic opportunity for an experienced Senior Regulatory Affairs Contractor has become available within a leading Cell and Gene Therapy company based outside of London on a 2 to 3 day per week contract. The role will involve personally developing and implementing regulatory strategy for current product development, Clinical Trail submission and for Marketing Authorisation Submission.
Key Duties and ResponsibilitiesYour duties as the Senior Regulatory Affairs Contractor 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 Requirementso be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Contractor 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
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