Regulatory Strategist Director

1 mese 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 team, you will be responsible for 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, ensuring compliance with regulatory requirements and optimizing project delivery time and probability of success.
  • Partner with project teams and stakeholders to ensure required regulatory contributions meet business needs and quality standards.
  • Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
  • Serve as a member of the Product Labelling Team to contribute to the development and update of the CCDS and contribute to the development and maintenance of local labels as appropriate.
  • Ensure regulatory plans are monitored, progress is communicated to Senior Management, and any risks are mitigated.
  • Develop fit-for-purpose submission packages in collaboration with partner lines.
  • Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects/products.
  • Develop and maintain constructive working relationships with Health Authority contacts.
  • Support regulatory Due Diligence activities for business development opportunities.
  • Work closely with other Regulatory team members to ensure consistent and appropriate processes, systems, working practices, shared learnings, and quality standards.
  • Implement systems, processes, and procedures relating to regulatory strategy productivity improvements.
  • Understand current global and regional evolving regulations and guidelines, with the ability to assess the impact of these requirements on products/projects.
  • Ensure business compliance and implementation of and adherence to regulatory standards.
About You

We are looking for a candidate with a strong background in regulatory affairs, preferably with experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management.

The ideal candidate will have a proven track record of success in negotiating with major Health Authorities, demonstrated strategic thinking, and the ability to integrate strategies into actionable plans.

Strong written and verbal communication skills are essential, as well as the ability to deliver in a highly matrixed organization.

About Viatris

Viatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are committed to building a diverse, inclusive, and authentic workplace, where you can use your experiences, perspectives, and skills to make an impact on the lives of others.

We offer competitive salaries, benefits, and an inclusive environment where you can grow and develop your career. Some of our benefits include excellent career progression opportunities, work-life balance initiatives, a bonus scheme, health insurance, and a pension.

Viatris is an Equal Opportunity Employer.

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