Respiratory Bioequivalence Strategy Director

Viatris; Stone Cross; Sur place; GBP 150 000 - 190 000; Plein temps

Résumé du poste

Viatris seeks a Director Respiratory Bioequivalence Strategy Lead in the UK to shape BE strategy for respiratory products, collaborating across preclinical and clinical teams to align development with regulatory requirements. You will drive analytical strategy and ensure robust data to support submissions.

You will interact with cross-functional teams, write regulatory communications, and mentor others while maintaining up-to-date knowledge of BE science and regulatory guidance.

Qualifications

• Degree or equivalent in a life science or related discipline.
• Experience in development and/or application of analytical tests for bioequivalence.
• Experience contributing to regulatory submissions for respiratory products.
• Knowledge of regulatory guidelines for respiratory products and their interpretation.

Responsabilités

• Leads bioequivalence strategy input to project teams and directs execution of technical strategies for in-vitro/in-vivo relationships.
• Defines required pre-clinical/clinical studies with project teams to support development and regulatory submissions.
• Ensures high quality technical reports and regulatory submissions.
• Provides recommendations on development activities and regulatory strategy to achieve bioequivalence.
• Mentors teams on bioequivalence testing and represents Viatris in external scientific discussions and regulatory meetings.

Connaissances

Bioequivalence

Respiratory

Regulatory strategy

Project leadership

Analytical development

Formation

Life science degree

Description du poste

Viatris seeks a Director Respiratory Bioequivalence Strategy Lead in the UK to shape BE strategy for respiratory products, collaborating across preclinical and clinical teams to align development with regulatory requirements. You will drive analytical strategy and ensure robust data to support submissions.

You will interact with cross-functional teams, write regulatory communications, and mentor others while maintaining up-to-date knowledge of BE science and regulatory guidance.