Director, Respiratory Bioequivalence Strategy

1100 Mylan Pharmaceuticals Inc.; United Kingdom; On-site; GBP 120,000 - 160,000; Full time

Job summary

Viatris is seeking a Director Respiratory Bioequivalence Strategy Lead in Sandwich, England, United Kingdom, to drive regulatory bioequivalence programs for inhaled products.

You will lead strategy, collaborate with cross-functional teams, prepare regulatory submissions, and mentor staff while influencing industry and regulatory discussions to support product development and approval.

Qualifications

• Degree or equivalent in a life science or related discipline.
• Experience in development and/or application of analytical tests used in bioequivalence studies.
• Experience contributing to regulatory submissions for respiratory products or other complex products.

Responsibilities

• Leads bioequivalence strategy input to project teams and develops execution plans for in-vitro and in-vivo studies.
• Collaborates with pre-clinical and clinical leads to define necessary studies to support development and regulatory submissions.
• Prepares high-quality technical reports and regulatory submissions; communicates findings to stakeholders.

Skills

Bioequivalence strategy

Regulatory submissions

Analytical method development

Inhaled products knowledge

Cross-functional collaboration

Education

Degree in life science

Job description

Viatris is seeking a Director Respiratory Bioequivalence Strategy Lead in Sandwich, England, United Kingdom, to drive regulatory bioequivalence programs for inhaled products.

You will lead strategy, collaborate with cross-functional teams, prepare regulatory submissions, and mentor staff while influencing industry and regulatory discussions to support product development and approval.