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Regulatory Affairs Manager
2 months ago
Job title: Regulatory Affairs Manager
A Pharmaceutical company in London are seeking a Regulatory Affairs Manager to join their team. This role will be responsible for providing regulatory strategy for new marketing authorizations as well as life cycle management for their current products.
Responsibilities:
- Managing the life-cycle maintenance of all aspects of the MAs registered particulars.
- Generation and maintenance of summary of product characteristics, prescribing information, patient information leaflets and packaging components, including artwork management.
- Act as point of contact for Regulatory agency interactions including the preparation of briefing packages and strategy for meetings.
- Create and maintain SOPs and Work Instructions for the Regulatory team.
Requirements:
- Substantial experience within Regulatory affairs and Pharmaceutical industry.
- Significant post approval experience working with multiple products/projects.
- Knowledge related to the regulation of healthcare products, including regulatory frameworks, requirements, legislation, and processes.
- Proven experience in UK/IE Markets.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via
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