Regulatory Affairs Director - Zurich

2 days left

Location
Glattbrugg, Switzerland
Salary
Competitive
Posted
09 Feb 2021
Closes
11 Mar 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
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.
Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career .
What you can expect of us
As we work to support patients, we also take care for our employees' professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.

Including:
  • Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
  • Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
  • Flexible workplace environment, home office opportunities, competitive vacation entitlement
  • Attractive financial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans
Join Vifor Pharma Talent Community
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community .

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