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In this challenging role you will work under limited supervision to provide strategic and operational regulatory direction for clinical drug development programs through development, registration and approval/post approval. You will also be responsible for ensuring the execution of regulatory plans in line with global regulatory strategy in close collaboration with the Regulator Affairs Director.
For details of the client, location and a full job description contact Alan Brophy on + 41 (0) 612 254 277 or email email@example.com
*Science based BS or MS with requisite experience and demonstrated capability.
*Fluency in English as a business language. Additional languages an asset
* 2-4 years involvement in regulatory affairs and drug development
*Experience with regulatory submission and approval processes in 1 or more major regions (EU, Switzerland, China, Australia, NZ, growing markets in Asia and Eastern Europe).
*Experience in HA negotiations.
*Experience with life cycle management activities and post-marketing maintenance
*Experience in HA negotiations
*Analysis and interpretation of efficacy and safety data from a regulatory perspective.
*Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry (preferred).
*Strong interpersonal, communication, negotiation and problem solving skills.
To further details and a confidential consultation please contact Alan Brophy on + 41 (0) 612 254 277 quoting reference GPRM 12-001. To apply please click the apply button or email firstname.lastname@example.org with a copy of your CV and short cover letter detailing your suitability for the position. All applications and communications are conducted with the highest level of confidentiality.
Keywords: Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Executive, Regulatory Affairs Officer, Regulatory Affairs Scientist, CTA, Submissions, Variations Labelling, MAA, Switzerland, Freelance, Freelancer, Contract, Contractor, Clinical, Pharmaceutical
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
SRG, winners of the Recruitment Professional Awards 2011 'Best Company to work for' and 'Best People Development Business' awards, and the only "highly commended" company in the Annual Recruiter Awards for Excellence 2011, for 'Best Small Recruitment Agency to Work For'.