Regulatory Affairs Manager - ATMP

Dependent on Experience
24 Oct 2018
21 Nov 2018
Georgia Walden
Contract Type
Full Time
A fantastic opportunity for an experienced Regulatory Affairs Manager has become available within a leading Cell and Gene Therapy company based outside of London. They are looking to identify professionals with experience of ATMP, Orphan Drug or Biologics experience to join their growing team.


Your duties as the Regulatory Affairs Manager - ATMP will be varied however the key duties and responsibilities are as follows:

1. Contribute to regulatory strategy for Gene Therapy Products to support clinical development and approval of important therapies.

2. Prepare and write IMPD / IND submissions to EU and FDA markets.

3. Prepare Orphan Applications, PIPs, and PRIME submissions

4. Act as the point of contact for Regulatory Agencies including but not limited to the EMA, National Agencies and the FDA.


To be successful in your application to this exciting opportunity as the 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, Genomics, Biotechnology etc.) ideally with experience of leading Cell or Gene Therapy development programs.

2. Proven industry experience in a Regulatory Affairs setting where you are contributing to dossier content and strategy. Experience of ATMPs is ideal but experience of Orphan Drug products and Biologics will also be of interest.

3. A working knowledge and practical experience with clinical development of ATMP technologies is a benefit.

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 |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.