Shape the Future of Pharmaceutical Labeling Excellence
* Duration: 8 months temporary assignment, Start asap
* Location: Basel-Stadt, Switzerland
* Type: Temporary position
* Salary: CHF 55,- - 74,- / h
* ID: 03512
For our client, a leading pharmaceutical company in the Basel region, we are seeking an experienced Senior Global Labeling Manager (m / w / d). This innovative organization is at the forefront of global drug development and regulatory affairs, with a strong commitment to bringing life‑changing therapies to patients worldwide. The company operates in a dynamic, international environment where regulatory excellence and scientific innovation drive success.
Your Responsibilities
* Lead global labeling strategy for assigned pharmaceutical products and ensure regulatory compliance across international markets
* Develop and maintain core labeling documents including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS)
* Coordinate cross‑functional teams through Expert Labeling Task Forces (ELTF) to achieve consensus on labeling strategies and text optimization
* Represent regulatory affairs as core member in Safety Management Teams (SMTs) and regulatory sub‑teams for product development projects
* Conduct comprehensive labeling research analyzing competitor labels, study data, and international regulatory requirements
* Collaborate with country organizations to ensure timely implementation of global labeling changes and maintain international consistency
* Prepare high‑quality documentation supporting CDS modifications and responses to health authority inquiries
* Present labeling strategies to Global Labeling Committees and relevant regulatory boards
Your Profile
* Advanced degree in life sciences (BS / MS required, MD / PhD / PharmD preferred) with demonstrated regulatory expertise
* Essential: Minimum 4-6 years of proven, hands‑on experience specifically in global pharmaceutical labeling – this expertise is critical for success in this role
* Alternatively: Extensive 5+ years of direct global labeling experience within pharmaceutical industry or health authorities – global labeling background is non‑negotiable
* Deep specialization in global labeling processes, international regulatory frameworks, and cross‑market labeling strategies is absolutely required
* Strong leadership capabilities with proven ability to manage cross‑functional teams in matrix organizations
* Excellent communication skills in English as business language, additional languages advantageous
* Comprehensive understanding of medical terminology, drug safety information, and international regulatory frameworks with specific focus on global labeling requirements
* Project management expertise with strong negotiation and problem‑solving abilities
* Organizational awareness of pharmaceutical business priorities and departmental interrelationships
Advantages Nemensis
* Nemensis AG is your specialized personnel agency in the Life Sciences sector with headquarters in Basel
* Comprehensive consultation and support throughout the application process by our experienced consultants
* Access to an extensive client network and exciting positions in Northwestern Switzerland
* Fast and uncomplicated entry through individual guidance and consultation in the application process
Branche: Pharma‑Industrie
Funktion: Qualitätsprüfung
Anstellungsart: Temporäre Arbeit
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