Director, Global Regulatory Strategist

Responsibilities

• Develop and implement global and regional regulatory strategies for complex pharmaceutical products and projects
• Lead global Regulatory Teams and partner with cross-functional stakeholders including Clinical, Safety, R&D, and Commercial
• Manage the preparation, submission, and quality of correspondence and applications to regulatory agencies
• Act as a direct or indirect liaison with Health Authorities to facilitate prompt review and approval of applications
• Provide regulatory input for clinical development programs, risk/benefit assessments, and target label development
• Monitor regulatory plans, communicate progress to Senior Management, and mitigate emerging risks
• Support regulatory due diligence activities for business development opportunities and mentor junior colleagues

Requirements

• B.S. in a Scientific field (Advanced degrees such as Ph.D., PharmD., M.D., or M.Sc. are a plus)
• Extensive global and regional regulatory experience within the drug development lifecycle
• Proven track record of negotiating with major Health Authorities and leading such interactions
• Demonstrated ability to develop strategic regulatory plans and integrate them into actionable business objectives
• Experience working effectively within a highly matrixed organization
• Strong written and verbal communication skills with the ability to influence the regulatory environment

Benefits

• Competitive compensation package and excellent employer-matched pension scheme (up to 11%)
• 100% paid medical insurance and Employee Assistance Programme
• Focus on career progression with growth and development opportunities
• Emphasis on Health & Wellness programmes
• Life cover and 2 paid volunteer days per year

About the Company

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. Our mission is to empower people worldwide to live healthier at every stage of life by providing access to high-quality medicines at scale, currently reaching approximately 1 billion patients annually.