A leading Cell and Gene Therapy Company are looking for a Senior Regulatory Affairs Manager to join their team based in Central London. As the Senior Regulatory Affairs Manager you will support Cell and Gene Therapy development programmes with a focus on strategy development for pipeline products. You will support Clinical Trial and manufacturing initiatives and compile and submit Regulatory filings for development programmes.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. You will develop CMC and Regulatory Strategy for product and process development programmes and ensure that you GMP requirements for Cell and Gene Therapy products are maintained.
2. You will work cross functionally with Manufacturing and Analytical teams both internally and with external collaborators to ensure development programmes meet Regulatory requirements.
3. You will prepare Regulatory documentation to a high standard in a timely and costly manor. These could include but are not limited to Briefing packages, CTAs, INDs, amendments, safety reports and annual reports.
4. You will develop and maintain constructive relationships with Competent and Health Authorities to influence regulators towards appropriate risk evaluation management.
To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences Discipline (e.g. Biology, Molecular Biology, Biotechnology etc.) in addition to extensive experience in a Regulatory Affairs role, ideally with experience of ATMPs and GMO legislation.
2. Proven industry experience of developing regulatory strategy for Biological, ATMP or GMP products. Ideally, you will have experience of regulatory documentation such as INDs, IMPDs, CTAs, MAAs, or BLAs.
3. Knowledge of CMC requirements for Biologic therapies preferably with a regulatory focus where you have the ability to evaluate and implement regulatory strategy.
Key Words: Biopharmaceuticals | Biologics | ATMP | Cell and Gene Therapy | C> | Advanced therapies | Process Development | Clinical Development | Programme Development | CMC | Manufacturing | Regulatory Affairs | IND | IMPD | CTA | MAA | Module 3 | Quality | GMP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Georgia Walden
- Phone: 0203 910 2980
- Reference: J5633616
- Posted: 5th October 2020
- Expires: 2nd November 2020