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Partnerships in Clinical Trials 2014

Reference No: J13404

Regulatory Affairs Program Manager / Senior Regulatory Affairs Program Manager – Oncology
Salary dependent on experience
Comprehensive benefits package
Reference: J13404

The role
Due to expansion within the Oncology team our client, a major global pharmaceutical company, is recruiting for a Regulatory Affairs Program Manager.
This is a permanent office-based position in Hertfordshire which may offer flexibility for home working 1 – 3 days per week, after 6 months. The role does not involve line management, with focus on strategic input across labelling & life cycle management, as well as representing / supporting cross functional teams. The successful candidate will lead interaction with regulatory agencies during product development / life cycle management, working with EU affiliates. In addition you would plan lead and implement regulatory submissions of MAAs and CTA.

This company is over 100 years old and specialise in both pharmaceuticals and diagnostics. It has a fantastic reputation within Regulatory Affairs as well as the pharmaceutical industry as a whole and has been named as one of Britain’s Top Employers for 2013, as certified by the CRF Institute.

They have a strong oncology pipeline with products transferring from one phase to another, including Infectious Diseases, Diabetes, Rheumatology, Transplantation and Cardiovascular.

Candidate Experience:
•Educated to degree level or equivalent
•At least 5 years broad regulatory affairs experience
•Demonstrable track record of proving strategic input
•Must come from a large pharma background
•Centralised Procedure or MRP within the EU
•Oncology experience is highly desired
•Knowledge of drug discovery, development, manufacturing and marketing
•Stable track record

For more information, please contact or call us on 0118 952 2797.

Regulatory Professionals are more than just a recruitment agency; we offer a bespoke service, dependent on your specific needs as a candidate. We are ethical as well as dynamic, honest and passionate about what we do.

We also have an excellent referral scheme here at Regulatory Professionals. If you refer someone who we then go on to place, you would be eligible for £250 worth of shopping vouchers!

Key Words: CTA, MAA, Regulatory Affairs, MRP, CP, EU, Affiliate, Drug discovery, life sciences, oncology

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