Director Respiratory Regulatory CMC in Hatfield

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously to be a source of stability in evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We operate through:

• Access – Providing high‑quality trusted medicines regardless of geography or circumstances;
• Leadership – Advancing sustainable operations and innovative solutions to improve patient health;
• Partnership – Leveraging collective expertise to connect people to products and services.

Our global portfolio includes best‑in‑class brand‑name products, generics, complex generics, and other offerings across therapeutic areas. We are committed to creating healthier communities worldwide through education, outreach and better access to treatment.

The Director Respiratory Regulatory CMC role will:

• Cultivate sustainable and effective relationships across stakeholders, partners and customers to establish aligned regulatory strategies.
• Prepare and analyze global CMC submission documentation and maintain product compliance, managing CMC change control.
• Serve as liaison with regulatory agencies, oversee fulfillment of agency commitments and provide responses to agency queries, leading preparations and interactions for regulatory authority meetings.
• Manage, lead and contribute to the respiratory portfolio, individual projects and cross‑functional project teams.
• Participate in pharmaceutical industry conferences and serve as a representative on trade group advisory committees relevant to CMC functions.
• Monitor external competitor and regulatory environment and build knowledge into project strategies.
• Perform other duties or equivalent duties for other product types as assigned.
• Serve as the primary reviewer of global CMC strategic plans and documentation/submissions for assigned products, primarily within the respiratory portfolio.

About Your Skills & Experience

• Mandatory hands‑on CMC authoring experience (initial registrations or post‑approval variations).
• Mandatory hands‑on experience in Regulatory CMC for respiratory/inhaled products.
• High level of knowledge of development & commercial activities and cGMPs to assess technical, scientific & regulatory merits of CMC information.
• Extensive technical, functional and industry knowledge in shaping project strategy, reducing regulatory burden and improving regulatory flexibility across global markets.
• Advanced understanding of current and emerging regulatory requirements, criteria for submission & approval globally, and experience leading negotiations with regulatory authorities.
• Proven ability to partner with Regulatory, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders.
• Advanced written and oral communication skills (mandatory).
• Computer literacy with Microsoft Office Suite and Documentum‑based applications.
• Experience managing projects and matrixed teams, and/or serving as a people manager.
• Ability to participate in interactions with regulatory authorities to respond to requests.
• Demonstrated commitment to scientific & regulatory integrity & quality compliance.
• Ability to engage in external regulatory and pharmaceutical environment.
• Proven ability to deliver on time, cost and quality standards.
• Strategic thinking and ability to integrate strategies into actionable plans.
• Experience as a subject‑matter expert in relevant disciplines or recognized resource for regulatory domains including respiratory products.

We offer competitive salaries, benefits and an inclusive environment. You get career progression opportunities and work‑life balance initiatives.

Diversity & Inclusion at Viatris

We are dedicated to building a truly diverse, inclusive and authentic workplace.

Sustainability at Viatris

Corporate social responsibility is fundamental to our mission.

Viatris is an Equal Opportunity Employer.