Director, Respiratory Bioequivalence Strategy

Viatris; England; On-site; GBP 110,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Inclusive environment

Equal Opportunity Employer

Job summary

Viatris (Mylan Pharma UK Limited) is seeking a Director of Respiratory Bioequivalence Strategy to lead the development and execution of BE strategies for inhaled products. You will work with cross-functional teams to define studies, generate regulatory‑readable data, and present at regulatory meetings.

The role requires deep experience in bioequivalence, regulatory submissions, and collaboration with statisticians and external authorities; a strong track record in respiratory product development

Qualifications

• Degree in life science required.
• Experience with analytical tests used in bioequivalence studies.
• Experience contributing to regulatory submissions for respiratory or complex products.
• Experience influencing regulators or industry colleagues.
• Knowledge of inhaled product development and commercialization challenges.
• Understanding regulatory guidelines for respiratory products & interpretation for generics.
• Knowledge of biopharmaceutics and bioequivalence strategies for respiratory products.

Responsibilities

• Lead bioequivalence strategy input to project teams and develop technical strategy.
• Define required pre-clinical/clinical studies to support development for bioequivalence.
• Ensure high-quality technical reports and regulatory submission elements.
• Provide regulatory input and represent Viatris at regulatory authority meetings as needed.
• Collaborate with statistics SMEs to apply appropriate statistical methods.
• Mentor team members working on bioequivalence tests.
• Contribute to cross-industry/regulatory groups and external representations.

Skills

Bioequivalence strategy

Regulatory submissions

Analytical methods

Inhaled products

Regulatory guidance

Mentoring

Education

Degree in life science

Job description

Viatris (Mylan Pharma UK Limited) is seeking a Director of Respiratory Bioequivalence Strategy to lead the development and execution of BE strategies for inhaled products. You will work with cross-functional teams to define studies, generate regulatory‑readable data, and present at regulatory meetings.

The role requires deep experience in bioequivalence, regulatory submissions, and collaboration with statisticians and external authorities; a strong track record in respiratory product development