Regulatory Affairs Director - Zurich

Location
Glattbrugg, Switzerland
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
2932
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
About You

At Vifor Pharma, we have an excellent opportunity for a Regulatory Affairs Director to lead regulatory affairs activities for our ion-based phosphate binder product. This product is approved in EU, US, Japan and other international markets.

Key responsibilities (but not limited to)

  • Lead the RA activities for the product

  • Be the primary contact at Vifor for major topics related to Health Authority interactions
  • Coordinate support from relevant internal GRA sub-functions, external consultants and vendors.
  • Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained and up-to-date.
  • Work in close collaboration with Vifor Partner Business functions to integrate all aspects of global regulatory strategy
  • Drive GRA contribution to establish and maximise potential of the product
  • Ensure strategic submissions on plan
  • Develop regulatory strategy to deliver Target Product Profile (TPP) label
  • Provide regulatory input for differentiation versus current and future competition
  • Ensure GRA delivery of LCM related activities
  • Ensure that the interactions between Regulatory and other departments are managed optimally to enable achievement of program targets
  • Foster Vifor reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound regulatory policies
  • Contribute to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders.

Requirements

  • MBS, BA in a relevant scientific discipline, or BSN/BSc in Nursing. MA/MS or PhD in life sciences or chemical engineering, or PharmD preferred

  • At least 10 years' experience in pharmaceutical regulatory affairs
  • Direct experience interacting with national Health Authorities
  • Excellent knowledge of the process for developing and launching products in the EU and internationally, including direct experience with the Centralised Procedure
  • Fundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registration
  • Excellent verbal and written communication skills in English.
  • Experience in leading a regulatory group or cross-functional team
  • Prior involvement in US registrations or other registrations outside of the EU.
  • Well known in regulatory community in the EU with good Health Authority contacts.
  • Understanding and speaking German and/or French is a strong asset


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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