Regulatory Affairs and Pharmacovigilance Specialist

Regulatory Affairs and Pharmacovigilance Specialist focuses on at ferring pharmaceuticals, we help people around the world build families and live better lives.

What the role involves

• At Ferring Pharmaceuticals, we help people around the world build families and live better lives.
• Review and submit variations, renewals, new product authorisations and other regulatory filings, including packaging material.
• Managing the assessment and response process for Parallel Trade Import Notifications for the UK and Ireland.
• Handling requests for Certificates of Pharmaceutical Products (CPP) and special statements.
• Monitoring regulatory changes for the UK and Ireland, assess impact.
• Provide backup support for Regulatory Affairs, Pharmacovigilance, and the reporting of adverse events and product quality complaints.

Skills and requirements

• Life Science degree or equivalent.
• Minimum of 3 years Regulatory experience in a pharmaceutical company (ideally 5 years experience).
• Preferable to have direct experience of communicating with the UK Health Authority (the MHRA).

Confirmed role details

• Parental leave for both birthing and non-birthing parents.
• Extended support on family building journey.
• Imagine the power of your career when it’s Ferring + You.
• We operate a hybrid working arrangement with employees expected to work from the office for a minimum of 3 days each week – for this reason you should live within a reasonable comm.

Additional role context

• Update the local UK Pharmacovigilance System Master File (PSMF).
• Update data in the Regulatory Information Management System (RIMS).
• Act as Document Owner for assigned SOPs, policies and regulatory/PV documentation.