Regulatory Affairs And Pharmacovigilance Specialist
Ferring Pharmaceuticals
London, United Kingdom
Hybrid
Uk regulatory environment knowledge
Post-brexit regulatory requirements
Regulatory filings and variations
The role involves preparing, reviewing, and submitting regulatory filings including variations, renewals, and new product authorisations for the UK market
Job Summary
The role involves preparing, reviewing, and submitting regulatory filings including variations, renewals, and new product authorisations for the UK market.
Candidates must maintain the local UK Pharmacovigilance System Master File and ensure full compliance with Good Distribution Practice and Good Pharmacovigilance Practices.
Ferring offers an inclusive support package called 'Building Families at Ferring' which provides equal and accessible policies for all employees.
Matching Summary
The role involves preparing, reviewing, and submitting regulatory filings including variations, renewals, and new product authorisations for the UK market.
Skills & Requirements
Must-have
UK Regulatory environment knowledge
Post-Brexit regulatory requirements
Regulatory filings and variations
GDP and GVP compliance
PSMF maintenance
Nice-to-have
MHRA communication experience
Innovative solutions-driven mindset
Entrepreneurial spirit
Parallel Trade Import Notifications
RIMS data management
Key Requirements
Life Science degree or equivalent
Minimum 3 years pharmaceutical regulatory experience
Mandatory knowledge of UK post-Brexit regulations
Experience communicating with MHRA preferred
Work Rights
Must live within reasonable commutable distance to office