Head of Regulatory Affairs Labelling and Clinical Support - Zurich

Location: Switzerland - Glattbrugg/Zurich

Division: Regulatory Affairs

Company: Vifor Pharma

Seniority Level: Director

Medha Khanna

Senior Talent Acquisition Manager

+41 58 852 90 82

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About You

At Vifor pharma, we are recruiting for a Head of Regulatory Affairs Labelling and Clinical Support to join our global regulatory affairs department based at our offices in Glattbrugg, Zurich.

This position would suit an experienced regulatory professional with a strong track record of managing large teams and

Key responsibilities:

  • Effective management and leadership of the Regulatory Affairs Labelling & Clinical Support Group
  • Establishment of processes to ensure that strategic& operational support is provided in transparent manner with optimal prioritization and efficiency
  • Accurate and cost-effective resource budget
  • Coordinated scientific approach across Vifor products as evidenced by clinical planning approach in GRA Strategy documents. 
  • Lead Regulatory Affairs Labelling & Clinical Support Group: 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
  • Establishment of procedures to manage the group activities in clear and transparent manner including contribution to CSTs, coordination of external scientific writing vendors, provision of regulatory intelligence related to clinical and labelling requirements, etc.
  • 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 budgetiong and management of costs accordingly
  • Take on special strategic and organizational responsibilities in consultation with Head Global Regulatory Affairs

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
  • Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration
  • Excellent verbal and written communication skills in English

Required skills:

  • Strong team leadership skills with the ability to build and foster high-performing teams (both functionally and cross-functionally)
  • Demonstrated ability to build effective working relationships and successfully influence at all levels across organizations to achieve business goals
  • Strategic thinker, planner, and implementer with a proven track record practicing sound and timely judgment
  • Self-driven, with high energy and ability to work under stress and set priorities according to needs.
  • Takes a proactive approach in identifying service needs, facilitating flow of information and supporting processes, and maintaining a customer and service oriented approach to all activities.
  • Excellent organizational skills, with an ability to prioritize and to manage complex issues and coordinate multiple projects simultaneously

If this opportunity is of interest to you, please apply by submitting your updated CV via our careers portal.

About Us

Vifor Pharma Group is a global pharmaceuticals company. It holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

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