Regulatory Officer / UK & Ireland focus / Fixed-term Contract / Full or Part-time (flexible)

30,000 - 40,000
01 Nov 2018
08 Feb 2019
Regulatory Affairs, CMC

If you are looking for a Part-time Regulatory opportunity – look no further!!

Regulatory Officer with a UK & Ireland focus – this can be a full time role 3 days per week for 6 months, OR Full-time for 6 months.

This highly successful Specialist Pharma Company, seeks a Regulatory Officer for the UK & Ireland Team. You will be adept in Registrations and Post marketing/maintenance, seasoned in the following processes: CMC; CTD/Dossiers for MAA's (focus on Modules 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. BROMI Applications. Sunset Clauses.

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

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

Post approval activities for assigned projects including Type Ia, Ib and II Variations/Renewals & PSUR submissions according to agreed company procedures, timelines and objectives

Maintenance of registration data bases for assigned products

Management and checking of Artwork for assigned products in line with written procedures

Filing assigned products according to documented procedures

1-3 years working knowledge of Pharma Products.

Circa £32,000 basic pro-rata, plus 10% bonus and benefits is offered to the right candidate.

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, or by clicking apply now.