Head of Global Regulatory CMC Sciences – Based Anywhere in Europe
Location: Hatfield, England, United Kingdom (Remote within Europe)
Company: Viatris
Position Summary: The Head of Global Regulatory CMC is a senior leadership role recognized for global CMC regulatory expertise. The incumbent leads a team of CMC professionals, develops strategic CMC regulatory approaches, and ensures compliance and excellence across the product lifecycle for Viatris branded products, including biologics, generics, and complex generics. This role shapes the CMC regulatory vision, builds strong stakeholder relationships, and influences business decisions at the highest level.
Key Responsibilities
* Provides leadership and strategic direction to the Viatris Global Regulatory CMC team across all branded product formulations and authorized generics.
* Establishes partnerships with Global, Regional, and Local stakeholders from cross‑functional disciplines to expedite the registration of new products, line extensions, and life‑cycle changes.
* Provides input into new business development opportunities.
* Assures coordination and implementation of consistent standards and processes throughout the Global CMC regulatory teams.
* Establishes team objectives and operational/strategic plans aligned with the Global Regulatory Affairs team and other key stakeholders.
* Supports the and maintenance of relationships with global regulatory agencies to influence future CMC regulations and resolve specific product issues.
* Partners with corporate affairs, government affairs, and local policy leaders to achieve business policy objectives.
* Establishes and defines the roles and required competencies of the Global CMC team and implements strategies to enhance capacity and capabilities.
* Provides oversight and direction for performance management, talent acquisition, and succession planning.
* Collaborates with the Regulatory Policy and Intelligence team and Country/Regional Strategists to monitor and positively influence the global/local/regional CMC regulatory environment.
* Works with regulatory colleagues across business verticals to develop and strengthen relationships, harmonize practices, and deliver a single One‑Viatris voice.
* Collaborates with Global, Regional and Local Regulatory, R&D, Technical Services, Clinical Development/Medical Affairs and Commercial to develop HA and KOL interaction strategies that align with filing strategies.
* Fosters and increases engagement with Global Health Authorities.
* Contributes to CMC change management and continuous improvement projects.
* Closing date for applications: 2nd January 2026.
Required Skills & Experience
* A higher degree (MS, PhD, PharmD, MBA) is preferred.
* Extensive global CMC leadership experience is required with deep technical and business experience in a relevant R&D technical field.
* Demonstrable CMC experience across the drug development and commercial lifecycle with proven contributions.
* Experience across the product development lifecycle for products in key geographies, including leadership in complex and innovative product approvals.
* Experience in early product development including BD partnerships and diligence assessments.
* Experience with branded products and generic drug regulatory submissions and approvals, DMFs, CEP filings, and contribution to global compendial requirements.
* Experience with diverse dosage forms, including sterile products and medical devices, is desirable.
* Global regulatory experience including thorough knowledge of CMC aspects of clinical trials, commercial submission processes, and product life‑cycle management activities.
* Line management and leadership experience at a senior management level is essential.
* Demonstrable experience of effective delivery in a complex matrix environment.
* Knowledge of global policies, regulations and guidelines, with extensive technical, functional and industry knowledge in shaping project strategies and reducing regulatory burden.
* Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, and experience in leading negotiations and interactions with regulatory authorities.
* Possesses sound understanding of business expectations across partner lines with proven ability to partner with other Regulatory functions and cross‑functional teams.
* Strong understanding of pharmaceutical development and impact on global business outcomes.
Benefits at Viatris
* Excellent career progression opportunities
* Work‑life balance initiatives
* Bonus scheme
* Health insurance
* Pension
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. We foster a culture that values every employee’s unique perspective and strive to build teams that reflect the communities we serve. For more information on our commitment to diversity, equity and inclusion, please visit Viatris Diversity & Inclusion.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and empower people to live healthier at every stage of life. Learn more about our initiatives at Corporate Responsibility.
Viatris is an Equal Opportunity Employer.
Seniority Level
Executive
Employment Type
Full‑time
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