Regulatory Affairs Global Labelling Manager
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Talent Acquisition Consultant at Coopers Group AG - Life Science
End date: 31.08.2025
Can be fully remote
The RA Global Labelling Manager is responsible for the creation and maintenance of regulatory compliant, competitive, and up-to-date core labelling documents for assigned developmental programs.
Responsibilities:
* Serve as the labeling lead for all labeling related topics.
* Maintain regulatory compliant, competitive and up to date global labeling documents (Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products.
* Present to GLC on CDS changes.
* Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate.
* Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.
* Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
* Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries.
* Interact with COs to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the CDS.
* Contribute to RA activities regarding safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
* Contribute to/lead presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g., MSRB, PSB).
* Prepare and/or review PSUR RA input for assigned products.
* Review and release International Package Leaflets for assigned products.
* Contribute to global labeling management and continuous improvement initiatives.
* Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
* Represent GL during audits and inspections.
Experience:
* Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
* Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the pharmaceutical industry or Health Authorities.
* Strong interpersonal, project management, communication, negotiation and problem solving skills.
* Ability to lead cross-functional teams in a matrix environment.
* Good understanding of drug safety information.
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Other
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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