Company Overview
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. Our mission is to empower people worldwide to live healthier at every stage of life. We provide access at scale, supplying high‑quality medicines to approximately 1 billion patients around the world annually. We touch all moments of life, from birth to end of life, acute and chronic conditions, across a wide range of therapeutic areas. Our portfolio includes iconic brand‑name products, global key brands, generics—including branded and complex generics—and other offerings. We are committed to creating healthier communities worldwide through education, outreach and better access to treatment.
Role & Responsibilities
The Director of Regulatory CMC Sciences Project Management is an emerging senior‑level position responsible for the project management of large‑scale and complex manufacturing site transfers and alternate API sourcing activities, impacting Viatris internal sites and CMOs across core, complex and established brand portfolios.
Provides regulatory project management support for global, large‑scale and complex network optimization projects.
Acts as a matrixed manager to coordinate and align priorities across multiple projects, developing and maintaining submission planning tools, tracking and forecasting approval timing to enable supply continuity and minimize stock‑outs.
Provides team‑leader oversight for all contracted GRA resources.
Cultivates sustainable relationships across internal stakeholders (Ops, R&D, Quality, Sourcing) to drive global regulatory assessments, gap assessments, regulatory strategies and right‑first‑time submission packages.
Assesses and communicates regulatory risks, develops and tracks mitigation plans.
Uses technical and scientific knowledge in submission preparation and review, ensuring regulatory compliance through change control, external and internal regulatory requirements.
Presents and articulates issues for resolution, communicating regularly with stakeholders, providing consultation as a scientific/technical resource and mentoring colleagues.
Develops dashboards and metrics for reporting to stakeholders.
Serves as the single point of contact across a large portfolio of projects, managing up to 20+ ETW resources within a matrixed global organization.
Key Qualifications & Experience
Mandatory hands‑on CMC authoring experience (initial registrations or post‑approval variations) – a generalist knowledge across global regulatory affairs disciplines.
Proven capability in managing complex regulatory projects and use of project management tools.
Extensive knowledge of post‑approval variations for site transfers and alternate API sourcing, and of cGMP requirements to assess technical, scientific and regulatory merits of regulatory information.
Extensive technical, functional and industry knowledge to shape project strategy, reduce regulatory burden and improve regulatory flexibility across markets and therapeutic areas.
Advanced understanding of current and emerging regulatory requirements, submission and approval criteria globally.
Sound understanding of business expectations with proven ability to partner successfully with GRA leadership and senior stakeholders in achieving objectives.
Skills & Abilities
Advanced written and oral communication skills (mandatory).
Computer literacy with Microsoft Office Suite and Documentum‑based applications.
Experience managing projects and matrixed teams or serving as a people manager.
Advanced knowledge of global regulatory requirements.
Commitment to scientific and regulatory integrity and quality compliance.
Ability to engage with external regulatory and pharmaceutical environments.
Proven ability to deliver on time, cost and quality standards.
Demonstrated strategic thinking and ability to translate strategies into actionable plans.
Experience as a subject‑matter expert or recognized resource for specific regulatory domains.
Benefits
Competitive salary
Bonus scheme
Health insurance
Pension
Excellent career progression opportunities
Work‑life balance initiatives
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace. If your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may be the right candidate for this or other roles.
Diversity & Inclusion: Viatris values diversity and inclusion as essential to our mission. For more information, visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion.
Sustainability: Corporate social responsibility is fundamental to our mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life. For more information, visit https://www.viatris.com/en/about-us/corporate-responsibility.
Viatris is an Equal Opportunity Employer.
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