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Regulatory Manager
Role Overview
The role will be responsible for manage all aspects of UK Product Registration and communications with the MHRA. The Regulatory Manager will also be responsible for pharmacovigilance reporting.
Company Information
My client are one of the world’s leading generic phamraceutical companies with a portfolio of prescription, non-prescriptions and animal health products. With a global presence my client offer excellent career progression, an excellent reputation and exciting portfolio.
Role Requirements
Monitoring and interpreting of UK regulatory and pharmacovigilance legislation
Development of registration strategies and the preparation of product registrations/variations
Submitting registration documentation to the MHRA/VMD in order to be granted marketing authorisations (MAs) at the earliest opportunity
Checking packaging materials intended for submission to regulatory authorities and before final print in production
Keeping the data base and documentary records on the registration procedures and distributing relevant MA data
Local Responsible Person for Pharmacovigilance
Participate in regulatory agency inspections and audits
Person Specifications
Experience within a similar position (Regulatory Management within Human Pharma)
Strong contact network with the MHRA
Attention to detail
Ideally experience in handling pharmacovigilance
Package
Competative base salary
Contributory pension
Healthcare
Home working (50%)
Group Income Protection Insurance