Regulatory Labelling Manager

Shape global drug safety and compliance as a Regulatory Labelling Manager with a leading CRO consultancy.

R&D Partners is seeking a Regulatory Labelling Manager to join a leading consultancy in the CRO industry. This role focuses on regulatory affairs, particularly in labelling activities for innovator drugs on a global level. The position offers an exciting opportunity to contribute to lifecycle management and compliance within a dynamic and collaborative environment.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Prepare, revise, and compile informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and non-EU markets.
• Develop target product-labelling profiles.
• Manage creation and maintenance of CCDS, CCSI, RSI in collaboration with relevant departments.
• Ensure communication of new and updated CCDSs and Product Information to internal and external stakeholders.
• Escalate deviations and compliance issues to labelling governance bodies as necessary.
• Handle labelling documentation and informative texts for innovator drugs globally.

Key Skills and Requirements:

• Language Proficiency: Fluent business English or native English; additional EU language skills are a plus.
• Educational Background: Degree in pharmacy, medicine, life sciences, or a bachelor’s degree in science.
• Regulatory Affairs Expertise: Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs globally.
• Lifecycle Management: Experience in handling marketing authorizations and their lifecycle management.

For more information, please contact Henry LeLacheur.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

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

By submitting this application, you confirm that you’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.r-dpartners.com/privacy-policy/

R&D Partners is seeking a Regulatory Labelling Manager to join a leading consultancy in the CRO industry. This role focuses on regulatory affairs, particularly in labelling activities for innovator drugs on a global level. The position offers an exciting opportunity to contribute to lifecycle management and compliance within a dynamic and collaborative environment.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Prepare, revise, and compile informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and non-EU markets.
• Develop target product-labelling profiles.
• Manage creation and maintenance of CCDS, CCSI, RSI in collaboration with relevant departments.
• Ensure communication of new and updated CCDSs and Product Information to internal and external stakeholders.
• Escalate deviations and compliance issues to labelling governance bodies as necessary.
• Handle labelling documentation and informative texts for innovator drugs globally.

Key Skills and Requirements:

• Language Proficiency: Fluent business English or native English; additional EU language skills are a plus.
• Educational Background: Degree in pharmacy, medicine, life sciences, or a bachelor’s degree in science.
• Regulatory Affairs Expertise: Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs globally.
• Lifecycle Management: Experience in handling marketing authorizations and their lifecycle management.

For more information, please contact Henry LeLacheur.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

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

By submitting this application, you confirm that you’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.r-dpartners.com/privacy-policy/