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Hyper Recruitment Solutions
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Regulatory Affairs Manager

London, Greater LondonPermanent
Experience Dependant
Job Reference: J5631854
Updated On: 29/07/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Consultancy, Cell & Gene Therapy

Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - Clinical, Regulatory Affairs - Manager / Director / Executive, Regulatory Affairs - Biologics, Regulatory Affairs - ATMPs

Job Information

Role Overview

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.

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, 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
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper 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.