Head of Regulatory Affairs Labelling
An exciting opportunity has arisen for a Head of Regulatory Affairs Labelling at a pharmaceutical company in Zurich. The bright individual will be able to step up and grow organically within the company which is perfect for an individual who is looking for a career development.
- Effective management and leadership of the Regulatory Affairs Labelling & Clinical Support Group
- Establishment of processes to ensure that strategic and operational support is provided in transparent manner with optimal prioritization and efficiency
- Coordinated scientific approach across products as evidenced by clinical planning approach in GRA Strategy documents.
- Management of RA Labelling staff, RA Clinical Support group and RA Scientific Writing function
- Consultation with department product leads to understand support requirements from the Labelling & Clinical Support group
- Coordination with Head of LCM group (in CoE) to ensure effective dossier support and planning and execution of CCDS rollouts and related submissions
- Review of tools and staff to ensure optimal support of group activities
- Representation of GRA on designated governance committees as assigned (e.g. PRC, DRRB, DSB, xCMRST)
- Delineation of cost-effective solutions and resource, and budgeting and management of costs accordingly
- Take on special strategic and organizational responsibilities in consultation with Head Global Regulatory Affairs
Skills and Requirements
- Degree in life sciences. Masters or PhD in life sciences, or PharmD preferred
- Significant regulatory experience gained in an international pharmaceutical company with multiple products registered globally
- Extensive knowledge and experience with pharmaceutical product information and labelling
- Strong team leadership skills with the ability to build and foster high-performing teams
- Self-driven, with high energy and ability to work under stress and set priorities according to needs.
- Excellent organizational skills, with an ability to prioritize and to manage complex issues and coordinate multiple projects simultaneously
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.