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Hyper Recruitment Solutions
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Director of Regulatory Affairs

Experience Dependant
Job Reference: J5631852
Updated On: 13/02/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: 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

We are currently looking for a Director of Regulatory Affairs to join a leading Regulatory Consultancy based in commutable distance from both London and Cambridge who offer high quality services for Pharmaceutical and Biopharmaceutical companies. As the Director of Regulatory Affairs you will be responsible for leading client projects and offering expert regulatory advice to a wide range of clients with a focus on early development programmes in addition to product registration and life cycle maintenance activities.

This both an advisory and hands on position where you will have the ability to combine your Regulatory experience with your business acumen.

Key Duties and Responsibilities

Your duties as the Director of Regulatory Affairs will be varied however the key duties and responsibilities are as follows:

1. Focusing on EU markets you will lead Regulatory projects focused on early stage development programmes, advising on and preparing Orphan Drug Applications, PIPs, PRIMEs and MAAs.

2. You will act as the EMA main point of contact and lead on Scientific Advice and other advisory meetings with Regulatory Authorities.

3. Advise clinical development teams both internally and externally and offer expert interpretation of EU Regulatory procedures.

4. Provide direct line management as well as matrix management of internal teams as required.

5. Assist with business development activities by acting as Regulatory Subject Matter expert in prospective client discussions.

Role Requirements

To be successful in your application to this exciting opportunity as the Director of Regulatory Affairs we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline with extensive Regulatory Affairs experience within the Pharmaceutical or Biopharmaceutical sector.

2. Proven EU Regulatory experience is essential for this position with exposure to pre-MAA activities including but not limited to Orphan Drug Application, PIPs, PRIME, CTAs, IND/IMPD and Scientific Advise meetings.

3. The ability to liaise and negotiate with EU regulatory agencies is vital where previous experience of having submitted an MAA will benefit your application.

Key Words: Regulatory Affairs | EU | Centralised Procedures | PIP | Paediatric Investigation Plan | PRIME | ODD | Orphan Drug Designation | CTA | Clinical Trial Application | IND | IMPD | Scientific Advice | MAA | Marketing Authorisation Application | EMA
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.