Director Regulatory Strategist

3 giorni fa

Milano, Lombardia, Italia Viatris A tempo pieno
Job Title: Director Regulatory Strategist

Viatris is seeking a highly skilled Director Regulatory Strategist to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global and regional regulatory strategies to ensure compliance with regulatory requirements and optimize business outcomes.

About the Role

The Director Regulatory Strategist will be responsible for:

  • Developing and implementing global and regional regulatory strategies to ensure compliance with regulatory requirements and optimize business outcomes.
  • Partnering with cross-functional teams to ensure regulatory contributions meet business needs and quality standards.
  • Providing regulatory input to clinical development programs, risk/benefit assessments, and target label development.
  • Serving 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.
  • Ensuring regulatory plans are monitored, progress is communicated to Senior Management, and any risks are mitigated.
  • Developing fit-for-purpose submission packages in collaboration with partner lines.
  • Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products.
  • Developing and maintaining constructive working relationships with Health Authority contacts.
  • Supporting regulatory Due Diligence activities for business development opportunities.
  • Working closely with other Regulatory team members to ensure consistent and appropriate processes, systems, working practices, shared learnings, and quality standards.
  • Implementing systems, processes, and procedures relating to regulatory strategy productivity improvements.
About You

We are looking for a candidate with:

  • A BS. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
  • 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, other partner lines, and senior stakeholders to achieve objectives.
  • Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions.
  • Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
  • Proven ability to deliver in a highly matrixed organization.
  • Strong written and verbal communication skills.
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 truly 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.
  • Bonus scheme.
  • Health insurance.
  • Pension.

We are an Equal Opportunity Employer and welcome applications from diverse candidates.

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