Principal Regulatory Executive / CMC Variations / Drug Development / Lead Project Teams / Middlesex
- Contract Type
Principal Regulatory Executive – operate within cross-functional Project Teams, manage junior staff!! European and International Regulatory scope. Good CMC working knowledge.
The candidate will be responsible for planning Regulatory Submissions, mentoring and/or supervising the work of junior Regulatory Affairs staff, and may be required to Lead cross-functional Project Teams.
You will possess good al-round Regulatory skills and have working knowledge of: Drug Development Regulatory, Registrations and Post marketing/Life-cycle maintenance (particularly CMC Variations); proven experience in the life-cycle maintenance of Centrally Authorised Products.
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, Strategy, Tactics and Implementation experience.
Ideally, you will have an understanding of legislation in relation to foods and nutritional supplements.
5+ years working knowledge of Pharma and/or nutritional supplement products. Project management experience.
A good salary package is on offer, Circa £50,000-£55,000 basic, plus 15% 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 firstname.lastname@example.org, or by clicking apply now.
Apply for Principal Regulatory Executive / CMC Variations / Drug Development / Lead Project Teams / Middlesex
Already uploaded your CV? Sign in to apply instantly