REGULATORY AFFAIRS MANAGER - EUROPE in Madrid

Excellent Opportunity!!! - My client, a well-established global pharmaceutical company leader in generics, is currently looking for a Regulatory Affairs Manager Europe to join its brand new Research Institute that develops a strong pipeline of innovative drugs in Women´s Health, Infection and Cancer.

Based in Madrid office, reporting directly to the Research Institute Director, and functionally to the Chief Scientific Officer, in this position you will take care of all regulatory aspects of the development up to the filing of NDAs in Europe. The scope will cover RA issues related to CMC, preclinical and clinical activities. You should be able to attract and recruit a team and also to design the project strategy with Big Pharma, Biotech Pharma Companies and the European Agency.

Suitable candidates will hold a University degree. You will possess between 5 and 10 years of experience working in Regulatory Affairs. The leader should come from a strong Regulatory Affairs background in the industry and would have experience dealing with European Agency and Local Agencies on a variety of issues. You will have extensive experience and in depth knowledge of European regulatory requirements and filing strategies and dossier requirements for new products including NCE´s and NDA´s. Candidates must be fluent in English with additional languages (including Spanish) desirable though not essential. Energy and drive, with excellent communications skills are required.

In return my client offers the opportunity to join a strategic and expanding division with further career progression in a fast growing company, and a competitive salary package.

For immediate consideration regarding this role please send your CV to beatriz.deluis@secpharma.com or call me on + 44 (0) 207 255 6665 for further information.

This position, REGULATORY AFFAIRS MANAGER - EUROPE in Madrid, was posted on January 21, 2012. The job is located in Madrid. Since this job has been published, it has been viewed 23 times.