Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Manager to join a leading Biopharmaceutical consultancy company based in the Greater London area. As the Regulatory Affairs Manager you will offer internal and external clients expert Regulatory advice for Biopharmaceutical products at early stage development. You will use your Regulatory understanding of Biological products and EU procedures to act as the main point of contact for agency interactions and act as project lead on a range of client programmes.
This position will offer the successful Regulatory Affairs Manager the opportunity to work on a range of projects and products, broadening their Regulatory experience.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. Provide EU regulatory affairs advice to clients developing a wide variety of medicinal products including ATMP and GMO.
2. Act as Lead for EMA procedures including Orphan Applications, PIP's, Scientific Advice briefing documentation, IND, IMPD, PRIME submissions etc.
3. Lead Scientific Advice meetings with national and regional agencies including the MHRA, EMA and FDA.
4. Manage a range of projects at different development stages where you have direct contact with the Client and Regulatory Agency.
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, Biochemistry, Chemistry etc.) with a good technical understanding of Biopharma, Biological, ATMP and GMO products.
2. Proven industry experience in a European Regulatory Affairs environment where you have demonstrated the ability to liaise and negotiate with Regulatory Authorities.
3. Demonstrate experience with early stage product development in Scientific Advice meetings, CTA, Orphan Applications and/or PIPs.
Key Words: Regulatory Affairs | Manager | Senior Manager | Project Management | Clinical Trial Applications | PIP | Paediatric Investigation Plans | Orphan Applications | Scientific Advice | SA | Scientific Advice Briefing Packages | EMA | European Medicines Agency | MHRA | FDA | Biopharmaceuticals | Biologics | Cell Therapy | Gene Therapy
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: J5631854
- Posted: 13th February 2020
- Expires: 12th March 2020