Director Regulatory Affairs Global CMC

About Viatris

Viatris is dedicated to transforming healthcare by providing high-quality, reliable medicines to people worldwide across all stages of life. Our mission is anchored in accessibility, leadership through sustainable practices, and collaboration to connect individuals with vital pharmaceutical products and services. Our portfolio spans iconic brand-name medicines, generics (including branded and complex varieties), and serves a wide variety of therapeutic areas. We foster a collaborative and courageous culture for our employees to make significant contributions to global health.

Role Overview

The Director Regulatory Affairs CMC is a senior expert position responsible for leading the global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for the L-Upjohn product portfolio. This role independently crafts innovative regulatory approaches to accelerate the submission and review process, ensuring compliance and quality standards are met.

Key Responsibilities

• Establish and maintain collaborative, sustainable relationships with stakeholders and partners to unify regulatory strategies and policies.
• Interpret CMC regulatory requirements, devise strategies including innovative methodologies, evaluate associated risks, and prepare contingency plans.
• Apply scientific and technical knowledge to prepare and analyze global CMC submission documents, uphold product compliance, and oversee change controls.
• Ensure effective, efficient execution of CMC regulatory activities adhering to external regulations and internal quality standards.
• Act as liaison with regulatory agencies on specific CMC matters, supervise agency interactions, and provide timely responses to queries.
• Communicate issues clearly to key stakeholders, offering expert consultation within cross-functional and therapeutic teams; mentor colleagues by sharing expertise.
• Lead and contribute substantially to Upjohn projects and cross-functional initiatives.
• Deliver training related to compliance and HR policies, participate in learning forums, and exemplify Viatris’ values including integrity.
• Represent Viatris in industry conferences and on advisory committees relevant to CMC functions.
• Manage CMC-related responses to Medical Information queries.
• Participate in governance and steering committees; act as global CMC lead in Due Diligence activities when necessary.

Leadership and People Management

• Provide leadership and guidance to direct reports, oversee resource allocation, capacity, and budgeting with appropriate workload prioritization.
• Conduct performance management, support work-life balance, implement HR policies, and make hiring decisions.
• Engage in succession planning and foster talent development through cross-disciplinary learning opportunities and open communication.
• Serve as the primary reviewer for global CMC strategic plans and regulatory submissions.

Desired Skills and Experience

• Extensive hands-on experience in authoring CMC documentation for initial registrations and post-approval changes.
• Proven leadership experience managing matrixed technical teams and complex projects.
• In-depth understanding of development, commercial operations, and cGMP standards to evaluate CMC data and technical merits effectively.
• Advanced knowledge of regulatory requirements across global markets, with experience leading negotiations and agency interactions.
• Strong business acumen with demonstrated ability to collaborate across regulatory, manufacturing, quality, safety, medical, commercial, legal, and senior leadership stakeholders.

About Viatris Benefits

• Competitive and rewarding salary package.
• Clear pathways for career advancement.
• Initiatives promoting a healthy work-life balance.
• Bonus schemes, health insurance, and pension plans.

Diversity and Sustainability

Viatris values a diverse and inclusive workplace, encouraging candidates from all backgrounds to apply even if all criteria are not fully met. The company prioritizes corporate social responsibility by advancing sustainable operations and investing in community health. Viatris is an Equal Opportunity Employer committed to respect and integrity.