Senior Global Labeling Manager (m/w/d)
Infos sur l'emploi
- Date de publication :21 mars 2025
- Taux d'activité :100%
- Type de contrat :Durée indéterminée, Temporaire
- Langue :anglais (Courant)
- Lieu de travail :Haltingerstrasse 101, 4057 Basel
Aequor Consulting GmbH - that's us! A young, dynamic and motivated team that aims to bring companies and talents together. We do this both in personnel placement and in personnel staffing. Even with large, complex and international projects, we can rely on the support of over 4,000 colleagues from the headquarters of Aequor Technologies Ltd. We are pleased to support you according to our slogan - “We listen. We deliver."
We are looking for an experienced Senior Global Labeling Manager (m/w/d) to work with our customer, a renowned pharmaceutical company in Basel.
Responsibilities
- Lead all labeling-related activities and ensure compliance with regulatory standards
- Maintain up-to-date global labeling documents, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS) for assigned products
- Present proposed CDS changes to the Global Labelling Committee (GLC)
- Organize and lead the Expert Labelling Task Force (ELTF) to define labeling strategies and finalize labeling texts
- Represent Global Labelling (GL) in Regulatory Affairs (RA) Sub-teams and Safety Management Teams (SMTs)
- Conduct research on labeling topics, including competitor labels, regulatory requirements, and market-specific variations
- Develop high-quality documents supporting CDS updates and responses to health authority inquiries
- Collaborate with country organizations (COs) to ensure timely and compliant implementation of global labeling changes
- Support regulatory activities related to safety risk communications and portfolio stewardship
- Lead or contribute to labeling-related presentations at key committees and forums
- Review and approve International Package Leaflets and regulatory input for Periodic Safety Update Reports (PSURs)
- Mentor and support junior Global Labelling Managers
- Contribute to continuous improvement initiatives and review emerging regulatory guidelines
- Represent GL in audits and inspections to ensure compliance and best practices
- Tenure period : 01/04/2025 to 31/08/2025
Requirements
- Education: A science-based BS or MS with relevant experience; an advanced degree (MD, PhD, PharmD) is preferred
- Languages: Fluency in English is required, with additional languages being advantageous
- Experience: Demonstrated expertise and seniority in global labeling activities
- Possess extensive experience of at least 4–6 years in global labeling, or over 5 years in related pharmaceutical areas or Health Authorities
- Strong interpersonal, project management, communication, negotiation, and problem-solving skills
- Proven ability to lead cross-functional teams in a matrix environment
- High organizational awareness with a clear understanding of interdepartmental relationships and business priorities
- Sound understanding of medical and scientific terminologies
- A good grasp of drug safety information
Benefits
- 5 weeks holiday / 40h week
- Assumption of certification costs
- Reka-Card with a 20% discount on up to CHF 2,400
- Up to CHF 400 contribution to fitness subscription
