Regulatory Project Manager / Biotech / Rare Diseases

Turner Regulatory
East Sussex
10 Oct 2018
15 Oct 2018
Contract Type
Full Time
Regulatory Affairs Manager UK & Ireland. Outstanding opportunity for a Regulatory Affairs Specialist with a UK & Ireland focus!! Excellent salary package.

If you are, an experienced Regulatory Project Manager, or a Senior Regulatory Officer ready to take a step-up to Manager and possessing a background in UK Regulatory Affairs - this is the role for you. Southern Counties location.

This highly successful Biopharma Company, seeks a Regulatory Project Manager to manage UK & Ireland submissions. Reporting to the Head of Regulatory Affairs, you will be adept in CTA’s, Registrations and Post marketing/maintenance, seasoned in the following processes; CTA’s; CTD/Dossiers for MAA's (focus on Modules 1, 2 and 3, but also reviewing all Modules 1 to 5); European Procedures: National Submissions/MRP, DCP and Centralised Procedure; Post marketing/Life-cycle maintenance: Type Ia, Ib and II Variations and Renewals; Labelling/Artwork, PIL's and SmPC's. PSUR's.

You will liaise with Global Regulatory Affairs when required.

To recap, it is essential you possess experience in the following:

Preparation and dispatch of new products regulatory submissions for the UK & Ireland via National, DCP, MRP and CP and routes

Clinical Trial Applications (CTA’s)

Post approval activities for assigned projects including Variations/Renewals & PSUR submissions

4-6 years working knowledge of Pharma and ideally Biologic Products.

The company possess a superb portfolio of Biopharma Products in Rare Diseases.

An excellent salary package in offered, including car allowance, bonus and benefits.

Southern Counties location.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330, or by, or by clicking apply now.

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