Regulatory Affairs Labelling Manager

CK Group are recruiting for a Regulatory labelling manager to join a company in the Pharmaceutical industry at their site based in Welwyn Garden City on a on a contract basis for 12 months.

 

Salary: 

Daily - PAYE £367.54 - £376.97 per day or £487.50 – £525 per day Umb/Ltd (outside of IR35)

 

Regulatory Labelling Manager Role:

-Contribute to the global product team in crafting and maintaining the company Core Data Sheet (CDS), core Patient Product Information (cPPI), and key local product labels for the EU and US throughout the lifecycle of pharmaceutical products and devices, ensuring compliance with labeling requirements.

-Apply critical thinking and effective data messaging in the creation and maintenance of regulatory labeling documents, ensuring clarity and accuracy in product information.

-Lead or contribute to company documents and responses to Health Authority requests related to product labeling, facilitating clear communication and compliance with regulatory standards.

-Guide the product team and country affiliates in the implementation of CDS updates to local labels, ensuring consistency and adherence to global regulatory requirements.

 

Your Background:

• Bachelor's degree with solid proven experience in current therapeutic area focus in Regulatory Program Management
• Expertise with regulatory labelling and working on CCDS for EU and US. 
• Understanding of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) principles and data integrity. 

Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

 

Location:

This role is based at our clients site in Welwyn Garden City, with hybrid working for 2/3 days onsite required per week. 

 

Apply:

For more information, or to apply for this Regulatory Labelling manager please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).

 

It is essential that applicants hold entitlement to work in the UK


Please note:  This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.