Regulatory Affairs Manager

Location
London
Salary
Competitive
Posted
02 Apr 2019
Closes
30 Apr 2019
Ref
J5631198
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
A leading Cell and Gene Therapy Company are looking for a Regulatory Affairs Manager to join their team based in Central London. As the Regulatory Affairs Manager you will support Cell and Gene Therapy development programmes with a focus on Quality and CMC requirements for product and process development. You will ensure that quality standards are met in accordance with Regulatory and GMP regulations and that regulatory strategy plans for each programme are successfully implemented.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the 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 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.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the 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 regulated GMP environment, ideally with experience of process development of ATMPs.

2. Proven industry experience working with Biopharmaceuticals, ATMP or Novel medicinal products with a focus on Clinical development, Process development or CMC development. 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&GT | 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.