Head of Regulatory Affairs Labelling

Highly Competitive
  1. Permanent
  2. Operations
  3. Switzerland
Zürich, Switzerland
Posting date: 22 Jul 2020
This vacancy has now expired

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.

Job Responsibilities

  • 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

To Apply

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.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski, alex@proclinical.com or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.