Meera Pattni at CK Regulatory is currently recruiting for a Regulatory and Medical Affairs Officer to join a growing pharmaceutical company based in Watford, Hertfordshire.
Regulatory and Medical Affairs Officer Job Description
As Regulatory and Medical Affairs Officer, you will be responsible for maintaining marketing authorisations for both UK and Ireland to meet regulatory requirements. You will also provide a medical information service and monitoring/reporting of Pharmacovigilance cases to meet regulatory and legislative requirements.
Further responsibilities of this Regulatory and Medical Affairs Officer position include to:
- Respond to medical and product enquiries received from healthcare professionals and members of the public.
- Receive spontaneous reports of adverse events, follow up adverse events, communicate adverse events information to the central Pharmacovigilance department and report adverse event information to relevant regulatory authorities.
- Receive, follow up, report and monitor customer complaints.
- Review advertising and promotional material to ensure its compliance with relevant legislation and codes of practice.
- Prepare and present Pharmacovigilance and ABPI training for both head office and field based staff.
- Licence maintenance for existing marketing authorisations in the UK and Ireland.
- Assist in compiling new MAA for UK and Ireland.
- Coordinate artwork amendments and tracking of packaging modifications by liaising with appropriate personnel.
- Prepare, submit and follow up applications for export certificates to the MHRA/IMB.
- Compile, maintain and work to SOPs.
Qualifications, experience and skills required for this Regulatory and Medical Affairs position:
- Previous experience within either medical or regulatory affairs is essential.
- Knowledge of licence renewals beneficial.
- Experience liaising with regulatory authorities required.
- Life sciences degree essential.
- Excellent interpersonal skills.
- Ability to work independently.
How to apply:
Click here to apply online now.
For more information, please contact Meera Pattni at CK Regulatory on +44 (0) 1438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23491 in all correspondence.
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