Regulatory Affairs Global Labelling Operations Consultant

Regulatory Affairs Global Labelling Operations Consultant Full-time, permanent role EU locations – Germany, Switzerland, UK – Other EU locations available as long as you are fluent in German and English Fluent in German and English (Essential) Cpl Life Sciences is collaborating with a leading CRO to appoint an experienced Regulatory Affairs Consultant with strong, hands‑on end‑to‑end global labelling expertise. This role sits within a high‑performing global regulatory team and will play a key part in shaping labelling strategy, ensuring compliance, and driving global alignment across a diverse pharmaceutical portfolio. The position can be fully home‑based or office‑based. Key Responsibilities Provide expert insight into country‑specific labelling requirements, ensuring high‑quality, compliant product information across markets. Execute operational labelling activities with accuracy within a follow‑the‑sun model, collaborating across global time zones. Prepare, review, and maintain labelling components for regulatory submissions, variations, and CCDS updates. Maintain robust labelling databases, systems, and tracking tools. Support global labelling harmonisation and process improvement initiatives. Collaborate closely with regional teams to ensure local regulatory compliance. Monitor and interpret regulatory intelligence related to labelling requirements. Additional Requirement Hands‑on operational labelling expertise, with full understanding of the end‑to‑end labelling workflow. Fluent German speaker to support labelling for Switzerland and Germany. Direct experience working with Swissmedic, BfArM, and PEI, ensuring market‑specific regulatory accuracy and compliance. Skills & Experience Required Several years of experience in biotech/pharmaceutical regulatory affairs, including global labelling responsibilities. Proven experience with CCDS development and maintenance. Strong understanding of global labelling regulations and country‑specific requirements. Experience in matrix‑based, international teams. Strong attention to detail, excellent organisational skills, and ability to deliver high‑quality work in global virtual settings. Fluent in German and English, written and spoken.

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