Regulatory Executive or Senior / Life-cycle / CMC & non-CMC / Middlesex

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

Regulatory Executive/Senior – European and International Regulatory scope. Good Regulatory Life-cycle working knowledge.

You will possess good al-round Regulatory skills and ideally will have working knowledge of: CMC & non-CMC combination; Drug Development Regulatory, Registrations and Post marketing/Life-cycle maintenance – National MRP and DCP; good knowledge in the life-cycle maintenance of Centrally Authorised Products is a good advantage.

You will be adept in Registrations and Post marketing/maintenance, seasoned in the following processes: Development Regulatory; 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 particularly Centralised Procedure; Post marketing/Life-cycle maintenance: Type Ia, Ib and II Variations and Renewals; Labelling/Artwork, PIL's and SmPC's.

Regulatory Planning. You will actively participate as Regulatory resource in cross-functional Project Teams. Liaise with Partners for in-licenced and out-licenced Products and secure that MAA’s are supported and/or maintained in accordance with agreements.

3+ years working knowledge of Pharma Products. Project Management experience an advantage.

A good salary package is on offer, Circa £37,000-39,000 basic, plus 10% bonus and benefits. Middlesex 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, or by clicking apply now.