Senior Regulatory Associate / CMC & Life-cycle / North West London/Middlesex
4 days left
- Contract Type
Senior Regulatory Associate – operate within cross-functional Project Teams!! European and International Regulatory scope. Good CMC and Life-cycle working knowledge.
The candidate will be responsible for planning Regulatory Submissions, mentoring, and may be required to operate within cross-functional Project Teams.
You will possess good all-round Regulatory skills and have working knowledge of: Registrations and Post marketing/Life-cycle maintenance (particularly CMC Variations); proven experience in the Life-cycle maintenance of Centrally Authorised Products. Any Pre-Registration experience would be welcomed, but not necessarily essential.
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.
3-4+ years working knowledge of Pharma and/or nutritional supplement products. Project management experience.
A good salary package is on offer, Circa £40,000-£55,000 basic, plus 10%-15% bonus and benefits (depending on experience). North West London/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 email@example.com, or by clicking apply now.
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