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Job Details

PW 6709 Regulatory Affairs Manager / Senior Manager

Company: AXESS
Location: West of London
Reference: PW 6709
Closing Date: 21 Dec 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.

Requirements:

BACKGROUND:

Global pharma specializing in Oncology

Based West of London (M4 / M4O / M25)

 

PRIMARY DUTIES:

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.

 

TO APPLY:

For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW 6709.

 

KEYWORDS:

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

 

ABOUT AXESS:

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

 

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

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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