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
KEY DUTIES AND RESPONSIBILITIES:
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.