AX 5119 Associate Director Regulatory Affairs – Oncology

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Category: Clinical Research, Regulatory Affairs Location: London , United Kingdom Job Reference: AX 5119 Job Type: Permanent Package details: Excellent Salary plus Competitive Bonus and Package

JOB SUMMARY:

Permanent office based position for an experienced Regulatory Affairs Associate Director to join the team at this respected Global Pharmaceutical Company. The offices are based in Central London.

BACKGROUND:

Global Specialist Pharmaceutical Company

Office Based Role within EU R&D Headquarters

Central London Offices

Waterloo / Charing Cross / London Bridge / Paddington / Blackfriars

PRIMARY DUTIES:

The position is specific to the regulatory support for oncology products

Plan, manage and execute regulatory activities in European territories as required on assigned oncology project or projects (either investigational or marketed products). May also be required to provide support to Director, Regulatory Affairs (Europe) – Oncology.

Develop innovative regulatory strategies for product development and approval for assigned oncology products (small molecule and biologics)

Prepare or facilitate preparation of documents to support regulatory submissions for assigned projects. (except clinical trial applications)

Participate in relevant team meetings on assigned projects to provide strategic European regulatory input and guidance to teams.

QUALIFICATIONS / EXPERIENCE REQUIRED:

BS degree or equivalent in science, advanced degree preferred

Ten years pharmaceutical/biological drug development experience with 8 year minimum regulatory experience

Proven European submissions capability, ideally in both pre-submission and post authorisation activities this must cover oncology projects

Experience in interactions with European Regulatory authorities in relation to all aspects of Regulatory activities

Detailed knowledge of EU regulations and guidelines on drug development and submissions both pre and post approval including oncology guidelines

Knowledge of eCTD

Good negotiation and communication skills and the ability to work independently and function well in a team-orientated environment

KEYWORDS:

Regulatory Affairs Associate Director / Oncology Reg Affairs Director / Regulatory Oncology Director / London / London / London / London / Permanent Regulatory Affairs jobs / careers / vacancies / positions / RA AD / Associate Director Regulatory Affairs

TO APPLY:

For a confidential discussion please telephone Paul Foster at AXESS Limited on 020 8560 2300 or, click on “apply now” below, to submit your details.

Only candidates with EU work authorisation will be considered.

 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