Job Details

Job Summary:

Regulatory Affairs Manager EU - South East Our client, a leading international Biotech, is currently looking for a dynamic individual for a Regulatory Affairs Manager position...

Requirements:

Regulatory Affairs Manager EU - South East

Our client, a leading international Biotech, is currently looking for a dynamic individual for a Regulatory Affairs Manager position within the EU division responsible for leading regulatory aspects of a product`s development, including strategic and project delivery.

Key responsibilities include;

- Be responsible for the regional strategy and execution of the preparation of MA and life cycle submissions
- Be responsible for the EU PIP submission strategy, PIP preparation and maintenance activities
- Be responsible for the regional strategy and as applicable execution of the regulatory aspects of the clinical trial program in the international region.
- Provide technical support for the creation review and finalisation of components of CTA and/or Marketing Applications as well as routine regulatory submissions

Required Qualifications are;

- Practical experience of the drug development process, from early phase to approval, as well as post-marketing experience.
- Regulatory experience in national, MRP, centralised products including understanding of the registration procedures in Europe (Centralised, Mutual recognition and Decentralised) for MAA, variations, extensions and renewals.
- Direct experience of contacts, meetings, presentations etc with EU regulatory authorities, including the EMA
- Relevant Bachelor`s degree is essential

This is a highly exciting opportunity for an ambitious individual looking to join a like minded company.

Due to the highly attractive nature of this career opportunity it would be advisable to register your interest at the earliest possible stage as we anticipate a high volume of applications.

Please do apply online or contact Josh Symons direct on 0207 2206 211

Keywords; Regulatory Affairs Europe Clinical Trials Drug Development Management Global Marketing Authorisations Post Licence Science Degree Pharmaceutical Middlesex London North East South West Hertfordshire Essex Buckinghamshire Kent Sussex Surrey Cambridgeshire Hampshire Berkshire Oxfordshire Bedfordshire UK United Kingdom England