For one of our clients, a pharmaceutical company headquartered in the Basel area, we are currently looking for a Labeling Manager who will be responsible for actively contributing to the development and implementation of regulatory activities for specific projects, serving as the regulatory representative on relevant project teams.
- Review and adapt the companies processes to changing requirements in Global Labeling thus play a key role in Process Improvements
- Managing the translation of EU Annexes within the framework of labeling variations or original MAA
- Coordinating translations of CTA relevant documents
- Maintains a database of translators, including an appraisal procedure for evaluating translation agencies and individual translators along professional lines
- Maintains a database of world-wide approved labels
- Managing effective working relationships with stakeholder departments and affiliates within the company
- Ensure compliance with internal policies on labeling.
- Ensure harmonized worldwide safety labeling through a common Core Safety Data Sheet (CSDS).
- Interact with local DRA worldwide to ensure timely implementation of global safety labeling changes of CSDS in local product information, and ensure international consistency and compliance with the Core Product Safety Information.
Qualifications and Experience:
- Project management and organizational skills
- Excellent communication and organizational skills
- Good computer knowledge, including setting up databases
- Team spirit and the ability to work under strict timelines
- Fluent in English, knowledge of other languages is an advantage
- Relevant working/residency permit or Swiss/EU-Citizenship required