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Your New Company
Become part of a top-tier global healthcare organisation within the Regulatory Affairs division. The Regulatory Labelling team is committed to assisting product teams in crafting, refining, and executing regulatory labelling strategies and activities throughout the product lifecycle.
Your New Role
As a Regulatory Labelling Manager, your responsibilities will include:
- Creating and implementing strategies for developing and maintaining Core Data Sheets (CDS), offering expert advice to product teams.
- Writing and overseeing CDS, working closely with regulatory product leads and product teams to ensure precision and compliance.
- Designing and implementing strategies for EU and US product information packages, authoring and maintaining these essential documents.
- Leading and contributing to responses to Health Authority (HA) queries regarding EU and US labelling.
- Providing strategic regulatory advice for labelling in various regional markets, collaborating with relevant functions.
- Assisting in the implementation of CDS into Local Product Labels and managing any local label deviations.
- Offering specific guidance on regulatory labelling matters, including legislation, guidelines, and procedures, to the RAFT and Project teams.
- Leading or contributing to the creation and enhancement of working processes and standards.
What You Will Need to Succeed in This Application
- Extensive experience in a strategic global labelling position.
What You Will Get In Return
- 12-month contract, hybrid working outside of London
- Outside IR35
What to do now?Click Apply to send an updated version of your CV. You will receive a response within the week.
