Global Regulatory Strategy Director

Viatris; Dublin; Presencial; EUR 140.000 - 190.000; Jornada completa

Descripción de la vacante

Viatris is seeking a Director, Global Regulatory Strategist to drive strategic regulatory direction for its originator and complex product portfolio. The role leads global/regional regulatory plans, interfaces with Health Authorities, and collaborates with cross-functional teams to ensure timely approvals and lifecycle management.

The ideal candidate has strong strategic and negotiation skills, experience in a matrixed global organization, and a track record of delivering regulatory milestones

Formación

• B.S. Scientific Degree is required.
• Advanced scientific degree and/or business qualification may be an advantage but not essential.
• Global/regional regulatory experience with ability to impact strategy.
• Experience managing global/regional regulatory and registration activities.
• Experience delivering across multiple products and lifecycle stages.
• Proven ability to collaborate with senior stakeholders to achieve objectives.
• Proven track record of negotiating with major Health Authority(ies).
• Strategic thinking and ability to translate strategy into action.

Responsabilidades

• Develop global/regional regulatory strategies and plans for complex products.
• Lead regulatory sub-teams and coordinate cross-functional partners.
• Interact with Health Authorities and support submissions and variations.
• Support regulatory due diligence for business development opportunities.
• Monitor plans and communicate risks to Senior leadership.
• Contribute to label negotiations and TPL/CCDS updates.

Conocimientos

Regulatory strategy

Cross-functional leadership

Strategic thinking

Regulatory negotiation

Global/regional regulatory

Project delivery

Educación

B.S. Scientific Degree

Advanced scientific degree (Ph.D./Pharm.D./M.D./M.Sc.)

MBA or other business qualification

Descripción del empleo

Viatris is seeking a Director, Global Regulatory Strategist to drive strategic regulatory direction for its originator and complex product portfolio. The role leads global/regional regulatory plans, interfaces with Health Authorities, and collaborates with cross-functional teams to ensure timely approvals and lifecycle management.

The ideal candidate has strong strategic and negotiation skills, experience in a matrixed global organization, and a track record of delivering regulatory milestones