about 1 month ago
Job title: Regulatory Affairs Manager
A Pharmaceutical company in Berkshire 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.
- Liaise with affiliate companies to ensure the submissions of Marketing Authorisation Applications in their designated markets can be successful.
- the preparation of registration files and submission of MAAs in line with Regulatory
- 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
- Substantial experience within Regulatory affairs and Pharmaceutical industry.
- Significant post approval experience working with multiple products/projects.
- Proven experience in EU Regulatory Affairs within either a R&D or established products
- Experience across UK and EU markets would be beneficial.
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 Freddie.firstname.lastname@example.org