Director, Global Regulatory Strategy & Impact

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 150,000 - 210,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression

Diversity & Inclusion

Work-life balance

Job summary

Viatris seeks a Director, Global Regulatory Strategist to shape and execute regulatory strategies across global markets. You will partner with cross-functional teams to drive submissions, align with business objectives, and lead engagements with health authorities to secure timely approvals.

The role requires extensive regulatory experience in global strategy, strong leadership, and the ability to navigate complex regulatory environments across allergy and cardiovascular areas.

Qualifications

• Extensive regulatory experience in Global Regulatory Affairs Strategy.
• Hands-on authoring experience with registrations or variations.
• Strong ability to lead complex projects and coordinate cross-functional teams.

Responsibilities

• Develop and implement global/regional regulatory strategies aligned with business goals.
• Lead meetings and interactions with health authorities and partners.
• Oversee preparation and submission of regulatory dossiers and communications; ensure quality.
• Provide regulatory input to clinical development programs and risk/benefit assessments.
• Maintain up-to-date knowledge of global regulations and adapt strategies accordingly.

Skills

Regulatory strategy

Leadership

Global regulatory

Health Authority liaison

Regulatory submissions

Cross-functional

Education

Master's degree

Regulatory affairs experience

Job description

Viatris seeks a Director, Global Regulatory Strategist to shape and execute regulatory strategies across global markets. You will partner with cross-functional teams to drive submissions, align with business objectives, and lead engagements with health authorities to secure timely approvals.

The role requires extensive regulatory experience in global strategy, strong leadership, and the ability to navigate complex regulatory environments across allergy and cardiovascular areas.