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Regulatory Affairs Manager

Experience Dependent
Job Reference: J5634298
Updated On: 25/03/2021
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Medical Device, Nutraceutical, Life Sciences

Skills: Regulatory Affairs - Permanent, Regulatory Affairs - EU, Regulatory Affairs - UK, Regulatory Affairs - Global, Regulatory Affairs - CMC, Regulatory Affairs - FMCG, Regulatory Affairs - OTC, Regulatory Affairs - Drug Safety, Regulatory Affairs - Generics

Job Information

Role Overview

Are you an experienced Regulatory Affairs Manager looking for a new exciting job opportunity?

We are currently looking for a Regulatory Affairs Manager to join a leading pharmaceutical company based in the Hertfordshire area.

As the Regulatory Affairs Manager you will be responsible for providing comprehensive and broad-ranging regulatory expertise and management in all aspects of obtaining and maintaining market authorisations and other regulatory registrations/permits required by the company.

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 be responsible for providing regulatory strategy expertise in New Product Development, product maintenance as well as regulatory support to clinical development. Your role will include regulatory compliance guidance and support to other departments with a particular focus on CMC.

2. You will also be responsible for planning, organising and as necessary compiling and submitting applications for clinical trials, marketing authorisations, registrations, technical files, manufacturing authorisations as well as wholesale dealer's authorisations.

3. As the Regulatory Affairs Manager, you will be responsible for preparing and maintaining additional supporting regulatory documentation including product literature and technical reports.

4. Additionally, you will assist in reviewing labelling, advertising copy in accordance with regulatory standards as well as training and developing the regulatory team.

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. Proven relevant regulatory experience in medicines and experience in CMC is essential for this role, as there is a significant emphasis on technical aspects in the role (Modules 3).

2. As well as experience with medicines, regulatory experience in medical devices or cosmetics would be preferred and highly advantageous.

3. Ability to identify commercially effective approaches to regulatory problems and find innovative solutions, meticulous attention to detail, experience of document management systems and NeeS/eCTD submission is also required for this role.
Debra Fong
Your Recruitment ConsultantDebra
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.