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Job Details

PW 6709 Regulatory Affairs Manager / Senior Manager

Company: AXESS
Location: West of London
Reference: PW 6709
Closing Date: 27 Oct 16
Type: Permanent
Salary (£): Competitive
Benefits: Excellent

Job Summary:

An excellent opportunity for an experienced Regulatory professional to join one of our growing pharmaceutical clients, specialising in Oncology. This position will suit a senior Regulatory professional with both EU and US experience at Regulatory Manager / Senior Manager level. Office based to the West of London.



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.



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 quoting reference PW 6709.



Reg Manager / Global Regulatory Manager / Senior Global Regulatory Manager / Sen Reg Manager / EU Reg Manager US Reg Manager / London reg roles / UK  / Oncology Reg Manager / Reg Manager / Global Regulatory Manager / Senior Global Regulatory Manager / Sen Reg Manager / EU Reg Manager US Reg Manager / London reg roles / UK / Associate Director Regulatory Affairs / Oncology Reg Manager



AXESS has been operating since 1990

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Apply for this job:  PW 6709 Regulatory Affairs Manager / Senior Manager

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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