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Job type: Contract

Discipline: Labelling & Artwork

Location: United Kingdom

Keep the heartbeat of innovation running and join our client in this Regulatory Affairs Labelling position and ensure cutting-edge pharma operations never miss a beat!

��Ƶ is seeking a Regulatory Labelling Manager to support the development, optimization, and implementation of regulatory labelling strategies throughout the product lifecycle. This role involves creating and maintaining Core Data Sheets and regional product information documents, as well as providing strategic guidance on labelling requirements. You will collaborate with cross-functional teams to ensure compliance and alignment with global and regional regulatory standards.

Responsibilities:

Develop and maintain Core Data Sheets (CDS) for medicinal products, ensuring alignment with regulatory requirements.
Provide guidance and expertise to product teams on CDS and supporting documentation.
Author and manage CDS processes in collaboration with regulatory product leads and product teams.
Create and maintain EU and US product information packages, including responses to health authority questions.
Offer strategic recommendations on labeling requirements for regional markets in collaboration with relevant functions.
Support the implementation of CDS into local product labels and manage any deviations.
Provide guidance on regulatory labeling issues, including legislation, guidelines, and procedures.
Lead or contribute to the establishment and improvement of labeling processes and standards.

Key Skills and Requirements:

Bachelor's degree or equivalent in life sciences or a related field.
Strong knowledge of regulatory affairs, particularly in strategic labeling; familiarity with market access is a plus.
Proven ability to lead cross-functional matrix teams with strong influencing skills.
Excellent interpersonal and verbal communication skills.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��Ƶ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��Ƶ is acting as an Employment Agency in relation to this vacancy.

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