Job Description Summary:
The European Labelling & Promotional Scientist is responsible for overseeing European labelling and promotional activities, providing regulatory expertise for a therapeutic business unit.
This includes ensuring compliance with labelling requirements, managing the creation and update of product information (e.g., SmPC, PIL, IFU), and liaising with internal and external stakeholders to ensure accurate regulatory submissions.
The role also involves leading readability testing, linguistic reviews, and promotional material approvals, while maintaining strong communication with cross-functional teams and monitoring changes in regulatory requirements. A key aspect is managing the EU Clearance Committee for promotional material compliance.
Key Responsibilities:
* Creation and maintenance of EU product information in compliance with regulatory requirements.
* Lead regulatory reviews for promotional materials, ensuring alignment with the approved EU label.
* Manage Readability Testing and linguistic review processes.
* Engage in the Local Labelling Committee and contribute to artwork and mock-up changes.
* Ensure communication of regulatory changes and updates to relevant teams
What are we looking for?
Required Education & Qualifications:
* Bachelor's or Master's Degree
* Strong experience in regulatory affairs and labelling activities.
Skills:
* Strong communication and influencing skills.
* Ability to build partnerships and work in cross-functional teams.
* High level of flexibility, adaptability, and organizational skills.