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Regulatory Affairs Executive

Hyper Recruitment Solutions
Dependent on experience
Closing date
11 Feb 2022

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Job Details

We are currently looking for a Regulatory Affairs Executive to join a growing pharmaceutical company based in the Hertfordshire area. As the Regulatory Affairs Executive you will develop and maintain comprehensive and broad-ranging regulatory expertise in all aspects of maintaining product regulatory compliance, as well as in obtaining and maintaining medicines / medical device certification.

- Competitive salary
- Beautiful rural location - own personal transport required
- Flexibility for some home working
- Small independent company


As Regulatory Affairs Executive, you will work as part of a small team of regulatory affairs professionals responsible for all regulatory aspects of gaining approvals for clinical investigations and marketing of the Group's medicines, medicinal devices, cosmetics and other product classes:

1. With a focus on medical devices, prepare and submit applications for certification of medical device technical files.

2. Assess, prepare and submit any necessary change notifications to maintain device registrations and technical files.

3. Prepare and maintain additional supporting regulatory documentation including product literature and technical reports.

4. Assist in reviewing documents for compliance with regulatory standards, specifications, guidelines and relevant codes of practice.

5. Maintain accurate and up to date regulatory documentation, including controlled documents, change control records and SOPs in accordance with the quality management system.

6. Provide regulatory compliance guidance and support to other departments particularly including Clinical Research, Pharmacovigilance, Pharmaceutical Development, Purchasing & Supply, Production, Distribution and Sales/Marketing.

7. Liaise, and foster constructive professional relationships within the business as well as with Regulatory Authorities, Notified Bodies, contract manufacturers and business partners etc. as required.

8. Develop knowledge of and keep up to date with, new or changing regulatory requirements impacting on planned and existing products and practices/procedures.


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

1. Relevant regulatory experience in medicines (ethical and OTC), medical devices or cosmetics. This experience should include handling pharmaceutical MAAs, renewals, variations and/or clinical trial applications in the UK/EU and/or experience of regulatory equivalents in other sectors. Whilst previous regulatory experience is preferred, it is not essential as full training will be provided.

2. Previous experience in a pharmaceutical environment

3. Computer competence (Microsoft Outlook, Word, Excel essential, PowerPoint and Project useful) and preferably experience of document management systems and eCTD submissions.

4. Personal qualities should include: Enthusiasm, Confidence in both giving and defending an expert opinion, A helicopter approach (able to take an overview and see different solutions), Good interpersonal skills

Key Words: Regulatory Affairs | Medical Devices | Cosmetics| Pharmaceutical | MAA | MDD | MDR

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.


Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:

• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments

HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website or contact us via
Telephone: 02032 255 120

Or any of the social media routes below: 
Linked in
Google +

Find Us
0203 910 2980
Amshold House
Goldings Hill
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