Senior Regulatory Affairs Labelling SME

MSI Pharma; London; Remote; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Labelling Strategist to thrive in a remote, flexible work environment. This role involves collaborating with top pharmaceutical companies and managing the end-to-end labeling process for mature and lifecycle products. The ideal candidate will have over 11 years of experience in Regulatory Affairs Labelling, showcasing strong analytical and project management skills. If you are ready to tackle complex regulatory challenges and lead a multidisciplinary team, this is the perfect opportunity for you.

Qualifications

• 11+ years of experience in Regulatory Affairs Labelling.
• Experience with CCDS or equivalent in a regulated environment.

Responsibilities

• Create and manage CCDS, US, and EU labeling for products.
• Provide strategic oversight on regulatory labelling projects.

Skills

Regulatory Affairs Labelling

Project Management

Analytical Skills

Leadership Skills

Education

Bachelor's degree in a scientific discipline

Tools

Company Core Data Sheet (CCDS)

Job description

Are you ready to thrive in a remote, flexible work environment? We're looking for a Senior Labelling Strategist specialising in regulatory labelling to join our client's team, collaborating with top Pharmaceutical companies through a leading service provider. For UK candidates the role will be inside IR35.

Responsibilities:

• Create, prepare, and revise CCDS, US, and EU labeling for mature and lifecycle products.
• Manage the end-to-end labeling process, including preparation, review, and approval.
• Provide strategic oversight and guidance on complex regulatory labelling projects.
• Collaborate with cross-functional teams and ensure regulatory compliance.
• Proactively address and resolve implementation challenges.
• Stay updated with EU regulations and deliver training to the labeling team.

Qualifications:

• Bachelor's degree in a scientific discipline or equivalent.
• 11+ years of experience in Regulatory Affairs Labelling within a highly regulated environment.
• Must have experience with "Company Core Data Sheet" OR "Core Data Sheet" OR CCDS OR CDS.
• Strong analytical, project management, and leadership skills.
• Proven ability to work effectively within multidisciplinary teams.

Please send suitable CVs ASAP for immediate feedback. Apply now!