Senior Manager Regulatory CMC / Project Leader / Top Biopharma

Location
London
Salary
Competitive
Posted
29 Apr 2021
Closes
29 May 2021
Ref
iF4e342iHI53
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Exciting Regulatory CMC role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; superb role. Regulatory CMC Development in Phases II to III, Registrations and some Post marketing activity. General Biologics and Pharmaceutical experience highly desirable. Rare Disease Products/Orphan Drugs. Pan-European and International focus. Matrix-management environment. Project Managing - this role is a combination of Strategy, Development, 'hands-on'.

The company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day management of Projects. The candidate will need to have a substantial background in Development Regulatory, ideally: IMPD's, IB's, Protocols, up-dates/amendments, and End of Trial Notifications - in conjunction with CRO liaison. CTD/Dossiers for MAA's (particularly Modules 3 and 2.3); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics, and Implementation; Regulatory Intelligence, Scientific Advice meetings with the EMA.

The successful candidate will possess a solid Regulatory CMC background within Biologics or Pharmaceutical of at least 6+ years. The candidate will demonstrate superb Project Management skills.

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