Regulatory Affairs Manager - EU Development in London

Reg Affairs Manager Role - Global Top 10 Pharma company just outside London. This is a company with very low turn-over and with one of the most high calibre Regulatory departments in Industry. This roles are European focused and will give you excellent project management experience with development products and life-cycle management. The more senior of the two positions would also give you the opportunity to mentor & develop 2 junior members of the department.

Both positions are similar in duties but will vary slightly in terms of their level of responsibility.

Overall Purpose:

- Lead submission and approval of a wide range of EU regulatory submissions including line extensions with direct management support
- Represent European Regulatory Affairs on one or more product development teams including those in late stage development
- Support senior colleagues on a key asset
- Consult EU Regulatory staff as necessary to formulate European position on tactical and strategic issues
- Provide solicited and unsolicited advice to product team members to ensure appropriate labelling, regulatory strategy, environmental influences are taken into consideration for a timely, high quality EU dossier to be compiled
- Maintain licences after approval, including fulfillment of commitments.
- Support clinical trial applications in European countries

Minimum Technical requirements:

- Comprehensive understanding and knowledge of European regulations
- Understanding of cross-functional nature of drug development and regulatory implications and challenges
- Computer skills (Word, Excel, Power Point)

Full job description available upon request.

This position, Regulatory Affairs Manager - EU Development in London, was posted on April 3, 2011. The job is located in London. Since this job has been published, it has been viewed 22 times.