For a confidential consultation call Beatriz de Luis on 0044 (0) 207 255 6665 or email your CV to beatriz.deluis@secpharma.com
Job Summary:
My client, growing global pharmaceutical company, is currently looking for an EU Senior Regulatory Affairs Manager to join its team in Madrid. In this position you will report to the Global CSO and will be responsible for the Regulatory Strategy to implement in Europe.
Accountabilities/Responsibilities:
Based in Madrid office, reporting directly to the Chief Scientific Officer, in this position you will take care of all regulatory aspects of the development from the strategic aspects up to the filing of MAA 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 Agencies.
Essential Skills & Capabilities:
Suitable candidates will hold a University degree. You will possess more than 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 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 Marketing Authorization Applications. 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 further details or a confidential conversation please contact me directly:
Beatriz de Luis
Pharmaceutical, Healthcare & CRO Division
Spain and International Biotech
Tel: +44 (0) 207 255 6665
Beatriz.deluis@secpharma.com
http://uk.linkedin.com/in/beatrizdelulis