Location: West of London
Reference: PW 6709
Closing Date: 27 Oct 16
Salary (£): Competitive
Global pharma specializing in Oncology
Based West of London (M4 / M4O / M25)
Under the direction of the Global Senior Director, Regulatory Affairs, you’ll independently prepare and direct global regulatory affairs activities with emphasis on Europe.
Provide regulatory guidance during drug development, approval and post approval processes and commercialization, in coordination with both the internal and external consultants and contractors in the oncology therapeutic area.
Initiate interactions and negotiations directly with regulatory authorities during the drug development and approval processes following an agreed upon plan. Conduct the regulatory activity to ensure high quality, regulatory integrity and completeness of all projects, including IND, NDA, IMPD and CTA submissions.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
Experience in particular of EU and US markets for regulatory submissions preferably in Oncology.
Experience of developing and implementing regulatory strategy for early and late stage of clinical development with strong emphasis of approval through launch to post marketing commercial support.
Previous experience managing regulatory affairs functional areas and external CROs and consultants.
Substantial knowledge of and experience interacting and negotiating with US regulatory agencies.
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW 6709.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
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