Director Regulatory Strategist

13 ore fa

Milano, Lombardia, Italia Viatris A tempo pieno
About the Role

Viatris is seeking a highly skilled Director Regulatory Strategist to join our team. As a key member of our regulatory affairs department, you will play a critical role in developing and implementing global and regional regulatory strategies for complex projects and products.

Key Responsibilities
  • Develop and implement global and regional regulatory strategies for complex projects and products
  • Partner with project teams and stakeholders to ensure regulatory contributions meet business needs and quality standards
  • Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development
  • Ensure regulatory plans are monitored, progress is communicated to senior management, and risks are mitigated
  • Develop and maintain constructive working relationships with health authority contacts
  • Support regulatory due diligence activities for business development opportunities
  • Implement systems, processes, and procedures to improve regulatory strategy productivity
Requirements
  • BS or advanced scientific degree (Ph.D., Pharm.D., M.D., M.Sc.)
  • Relevant global and/or regional regulatory experience
  • Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation
  • Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management
  • Proven ability to deliver to time, cost, and quality standards
  • Proven ability to partner successfully with regulatory, commercial, safety, medical, and other partner lines and senior stakeholders
About Viatris

Viatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are committed to helping create healthier communities through education, outreach, and better access to treatment. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.

What We Offer
  • Competitive salaries and benefits
  • Excellent career progression opportunities
  • Work-life balance initiatives
  • Bonus scheme
  • Health insurance
  • Pension

Viatris is an equal opportunity employer and welcomes applications from diverse candidates.

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