Director Regulatory CMC Sciences Project Management

About Viatris

Viatris is a global healthcare firm bridging generics and branded medicines to comprehensively meet global health needs. We supply high-quality medicines to around 1 billion patients annually worldwide, supporting health from birth to end of life across acute and chronic conditions. Our portfolio includes iconic brands, generics, complex generics, and diverse therapeutic solutions. We prioritize creating healthier communities via education, outreach, and improved treatment access.

Viatris fosters a collaborative culture encouraging courage and resilience, providing employees with opportunities to realize their full potential while making a meaningful difference globally.

Role Overview

The Director of Regulatory CMC Sciences Project Management is a senior role recognized for deep expertise in managing complex global post-approval regulatory changes. This position mainly focuses on overseeing large-scale, multifaceted manufacturing site transfers and alternate API sourcing projects affecting internal and external production sites within Viatris' core, complex, and established brand portfolios.

Key Responsibilities

• Deliver regulatory project management for extensive global network optimization initiatives.
• Function as a matrixed leader coordinating priorities across multiple projects, developing tools for submission planning, tracking, and forecasting approval timelines to support uninterrupted supply and limit stock-outs.
• Lead and oversee all contracted Global Regulatory Affairs resources.
• Cultivate strong relationships across internal functions (Operations, R&D, Quality, Sourcing) to drive regulatory assessments and ensure well-grounded gap analyses, strategies, and high-quality submissions.
• Evaluate regulatory risks and implement mitigation strategies, supporting submission preparation and review to ensure compliance with Change Control and regulatory systems.
• Effectively communicate issues for resolution and provide expert consultation across departments and therapeutic teams, mentoring colleagues.
• Develop dashboards and reporting metrics for stakeholder updates.
• Serve as the main internal contact for a large project portfolio, managing over 20 matrixed team members globally.

Required Knowledge and Experience

• Extensive hands-on experience in authoring CMC documentation for initial registrations and post-approval variations, with broad knowledge of global regulatory affairs.
• Demonstrated ability managing complex regulatory projects using project management tools.
• In-depth understanding of post-approval variations related to site transfers and alternate API sourcing, with strong cGMP knowledge for assessing technical and regulatory compliance.
• Broad technical, functional, and industry insight to develop strategies that reduce regulatory workload and improve flexibility across diverse markets and therapeutic areas.
• Advanced awareness of current and evolving global regulatory requirements and submission criteria.
• Business acumen with proven capability partnering with senior leadership to meet objectives.

Skills and Competencies

• Excellent written and verbal communication abilities.
• Proficient in Microsoft Office and Documentum-based systems.
• Experience managing projects and matrix teams, including people management responsibilities.
• Deep knowledge of global regulatory environments.
• Commitment to scientific and regulatory integrity and compliance.
• Ability to engage effectively in external regulatory and pharmaceutical environments.
• Track record of meeting deadlines within time, cost, and quality constraints.
• Strategic thinker able to translate strategies into actionable plans.
• Recognized as a subject matter expert in relevant pharmaceutical science or regulatory domains.

Culture and Inclusion

Viatris embraces diversity and inclusion as core to its mission, welcoming applicants who may not meet every requirement but bring potential to contribute meaningfully. The company is an Equal Opportunity Employer committed to building an authentic workplace supporting all employees.

Benefits

• Opportunity for career advancement
• Work-life balance initiatives
• Bonus incentives
• Health insurance coverage
• Pension plans