Global Regulatory Strategy Director

1100 Mylan Pharmaceuticals Inc.; Washington (District of Columbia); Híbrido; USD 112.000 - 236.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Competitive compensation

Descripción de la vacante

Viatris seeks a Director, Regulatory Strategist to lead global regulatory strategies for complex programs, including INDs, NDAs and MAAs, across US/EU/EM. You will partner with cross-functional teams to ensure timely, high-quality submissions and maintain lifecycle plans.

The role requires extensive regulatory experience, strong strategic thinking, and proven negotiation skills with major Health Authorities; it is a hybrid DC-based position with competitive compensation.

Formación

• Minimum 8 years of US, EU, EM Regulatory experience required.
• Minimum 5 years of Global Regulatory experience preferred.
• Combination of experience and/or education will be taken into consideration.
• Extensive knowledge of regulatory environment and ability to leverage this for strategy.

Responsabilidades

• Develop global/regional regulatory strategies and implementation plans for complex projects/products including post-approval activities.
• Partner with Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal to meet business needs and quality standards.
• Lead regulatory submissions and maintain Marketing Authorizations; organize meetings with Health Authorities.
• Provide regulatory input to clinical development programs and risk/benefit assessments; monitor plans and communicate risks.

Conocimientos

Regulatory strategy development

Global regulatory experience

Health Authority negotiations

Stakeholder collaboration

Regulatory submissions (IND/NDA/MAA)

Communication skills

Educación

B.S. Scientific Degree

Advanced scientific degree or MBA preferred

Descripción del empleo

Viatris seeks a Director, Regulatory Strategist to lead global regulatory strategies for complex programs, including INDs, NDAs and MAAs, across US/EU/EM. You will partner with cross-functional teams to ensure timely, high-quality submissions and maintain lifecycle plans.

The role requires extensive regulatory experience, strong strategic thinking, and proven negotiation skills with major Health Authorities; it is a hybrid DC-based position with competitive compensation.