Head of Regulatory Affairs Austria and Switzerland (m/f/d) – fixed term for 18 months

☞ Viatris

View: 162

Update day: 26-03-2024

Location: Zug Zug ZG

Category: Legal / Contracts

Industry: Biotechnology Hospital & Health Care Pharmaceuticals

Position: Director

Job type: Full-time

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Job content

7087 Mylan Pharma GmbH

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We Do So Via

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Key Responsibilities For This Role Include

Every day, we rise to the challenge to make a difference and here’s how the Head of Regulatory Affairs role -fixed term for 18 months for our Swiss and Austrian sites will make an impact:
  • Research and keep informed of updates EU and CH Regulatory legislations and guidance as they pertain to pharmaceuticals, Medical devices, food supplements and cosmetics
  • Provide interpretation of EU and CH policies and procedures
  • Establish and provide strategic leadership and oversight of the Regulatory function
  • Attend and participate in authority inspections and meetings as well as lead regulatory discussions with local Health authority
  • Support the coordination of Drug and Medical Device Recalls and Advisory Notices
  • Oversee all regulatory documentation prepared and submitted, monitor compliance and report progress periodically as require by corporate management
  • Support the maintenance of operational/expense budget and capital budget for the Regulatory Affairs Department
  • Provide regulatory support and leadership on internal cross-functional project teams
  • Review and maintain local compliance program Review promotional material/ marketing material (incl. online media) for Scientific and regulatory compliance
The Minimum Qualifications For This Role Are
  • Medical, Pharmacy or Life-sciences University degree (or equivalent), PhD preferred
  • Minimum 5 years of working experience within the pharmaceutical industry and within Regulatory Affairs
  • Very good knowledge of national, EU and Swiss regulations and regulatory guidance, policies and procedures
  • Profound knowledge of Medical Device regulations
  • Demonstrate ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally
  • Possess an excellent interpersonal, verbal, and written communication skills in English and German
  • Experienced in leading and working in cross-functional teams
  • Experienced in leading and working in a virtual team
A t Viatris, we offer competitive salar ies , benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.
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Deadline: 10-05-2024

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