Regulatory Affairs Managers / Associate Manager Vacancies

Regulatory Affairs Manager / Associate Manager VacanciesWe handle many vacancies for experienced regulatory affairs managers. Below you'll find an example of a typical Job. Login to find our current vacancies.

This international CRO is expanding in Europe and is looking to recruit an experienced regulatory professional to support a small team in the UK. The role is office based in the Home Counties and travel will be minimal. Reporting to the Manager, Regulatory Affairs you will review and produce regulatory documentation to approve the initiation of clinical trials and shipment of clinical trial supplies for compliance to regulations. You will also provide 'consultancy services' for in-house clinical trials or stand alone regulatory projects. In this role you will use electronic document management systems to enhance the regulatory submission process. You may also supervise junior staff. There is an excellent benefits package available including pension, private healthcare, life assurance, bonus scheme and 25 days holiday.

The successful candidate will have a BSc and four years' clinical research experience, teo years of which must have been spent in a regulatory role within a CRO. Experience with IND, CTA, NDA and MAA submissions is essential.
This international CRO is looking to expand its European regulatory team with the addition of a Manager, Regulatory Affairs (Europe), who will supervise the UK team with European regulatory activities. This is an office based role in the Home Counties and there will be minimal international travel. There are two regulatory associates in the group currently and you would be responsible for reviewing all regulatory documentation produced by the team. You will prepare and submit regulatory documents (IND, safety reports, interim reports) to support clinical trials and will also prepare NDAs on behalf of clients. There will be input into business development activities for full service clinical trials or stand alone regulatory projects. A competitive benefits package is available including pension, private healthcare, bonus scheme, 25 days holiday and life assurance.

To be considered for this newly created position you will be educated to degree level in a biological science subject and have at least six years' clinical research experience of which three years must have been spent in a regulatory role. CRO experience is preferred along with knowledge of FDA requirements.
Combine your clinical/medical writing and people management experience in this senior level role! In this role you will manage both processes, finances and people on an international level and will have direct responsibility for 6 clinical writers in Germany and the UK. Business development will also form part of your role for both full service and stand alone medical writing projects.

Previous experience in clinical writing is essential - specifically in the preparation of high level regulatory documents and other clinical study related documentation.

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