Regulatory Affairs Specialist, Weybridge, Surrey
£40k – £45k
Take responsibility for managing regulatory aspects of product development projects intended for inclusion into MAA’s and lifecycle management of approved Marketing Authorisations.
THE ROLE…
- Develop the technical quality data, non-clinical and clinical data of selected product to eCTD standard to support MAA.
- Prepare and submit new Marketing Authorisation Applications (MAAs).
- Manage regulatory aspects of product development projects for licenced products
- Complete QMS and financial management documentation promptly
- To keep up to date with regulatory and industry standards and apply to current projects.
- Travel to and spend time as required at supplier, contract manufacturer or other potential partner sites.
WHAT YOU WILL NEED…
- Previous experience of a Regulatory Affairs role, ideally with MAA experience and life-cycle management.
- Ability to prepare, review and maintain product information and CMC documentation.
- Experience of product development and new applications.
- Post marketing experience including variations, renewals and labelling
- Experience developing and implementing regulatory strategies.
- Ability to establish and maintain effective working relationships with internal and external stakeholders.
- Experience in writing / reviewing of IMPD’s/MAA’s.
WHY YOU WILL LOVE WORKING HERE…
Great team and collaborative environment, lots of opportunity within a growing successful business. Opportunity to gain experience with a global business. Company size allows for candidates to make their mark and have an impact on the business as a whole.
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