Role: Regulatory Labelling Manager
Location: Welwyn (Hybrid – with flexibility for remote working)
Hours: Full-time
Pay: 367.54 – 376.97 (PAYE basic) OR 487.50 – 525 (LTD / UMB) per day
Contract: 12-month contract outside IR35
An excellent opportunity has arisen for a Regulatory Labelling Manager to join one of our longstanding global pharmaceutical clients on a 12-month contract basis outside IR35.
This role sits within the Regulatory Affairs function, focusing on the development and delivery of global labelling strategies across the product lifecycle.
Benefits:
- 12-month contract outside IR35
- Hybrid working with flexibility for remote working
- Opportunity to work on global regulatory strategy
- Collaborative cross-functional environment
The Requirements:
- Degree in Life Sciences or a related field
- Strong experience within regulatory affairs, ideally with a focus on labelling
- Experience developing and maintaining Core Data Sheets (CDS)
- Knowledge of EU and US labelling requirements
- Experience working within cross-functional, matrix environments
- Strong communication and stakeholder engagement skills
The Role:
- Lead and optimise labelling strategies across the product lifecycle
- Author and maintain Core Data Sheets (CDS) and supporting documentation
- Develop and maintain EU and US product labelling documentation
- Provide strategic regulatory guidance on labelling requirements
- Support implementation of global labelling at local market level
- Respond to health authority queries related to labelling
- Collaborate with cross-functional teams to ensure alignment and compliance
- Contribute to process improvements and best practice within labelling activities
If you’re keen to join an exceptional team who can offer exposure to global regulatory strategy and high-impact product development, then please apply to this Regulatory Labelling Manager role below or call Chloe McCausland on (phone number removed) between 8:00am – 4:30pm.