Global CMC Regulatory Science Lead

Viatris; Ireland; On-site; EUR 100,000 - 150,000; Full time

Job summary

Viatris is seeking a Senior Manager, Regulatory Science CMC Complex to lead global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management. You will independently assess regulatory requirements, drive risk mitigation, and coordinate high-quality submissions with cross-functional teams worldwide.

You will mentor colleagues, oversee timelines, and act as the regulatory lead on major projects while building strong relationships with authorities and

Qualifications

• Bachelor's degree in a scientific discipline required; Master's degree preferred.
• Significant pharmaceutical industry experience, including regulatory affairs experience within CMC.
• Hands-on experience authoring CMC regulatory submissions for new registrations and/or post-approval variations.
• Strong understanding of pharmaceutical development, manufacturing processes, cGMP requirements, and lifecycle management.
• Experience supporting complex dosage forms such as drug-device combinations, injectable products, respiratory products, creams, or ointments is highly desirable.
• Advanced knowledge of global regulatory requirements, submission pathways, and regulatory expectations.
• Experience supporting submissions such as NDA, ANDA, supplements, amendments, DMFs, and comparable European procedures is preferred.
• Ability to interpret and apply global and regional CMC guidelines while contributing to regulatory strategy development.
• Excellent written and verbal communication skills with the ability to communicate effectively across all levels of an organization.
• Demonstrated project management skills and ability to manage multiple priorities in a fast-paced, global environment.
• Strong business acumen, problem-solving capabilities, and sound scientific judgment.
• Proficiency with Microsoft Office applications and regulatory document management systems.

Responsibilities

• Develop and execute global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management activities.
• Independently assess CMC regulatory requirements, identify potential risks, and develop mitigation strategies to support successful regulatory outcomes.
• Prepare, coordinate, and deliver high-quality global CMC regulatory submissions, including new registrations, post-approval changes, renewals, annual reports, and line extensions.
• Support Global Regulatory Leads or act as the Global Regulatory Lead for assigned products and major regulatory projects.
• Serve as the CMC regulatory representative on cross-functional project teams, partnering closely with R&D, Quality, Regulatory Affairs, Technical Operations, and regional stakeholders.
• Manage regulatory commitments, submission timelines, agency interactions, and regulatory intelligence activities with minimal supervision.
• Lead responses to health authority questions and provide quality review of complex regulatory submissions.
• Act as a scientific and technical subject matter expert, providing guidance, mentorship, and regulatory leadership to colleagues and project teams.
• Contribute to regulatory process improvements, strategic initiatives, and high-priority business projects that support the global complex products portfolio.
• Build and maintain effective relationships with regulatory authorities and internal stakeholders to enhance regulatory success.

Skills

CMC regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Project management

Communication skills

Education

Bachelor's degree in a scientific discipline

Master's degree preferred

Job description

Viatris is seeking a Senior Manager, Regulatory Science CMC Complex to lead global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management. You will independently assess regulatory requirements, drive risk mitigation, and coordinate high-quality submissions with cross-functional teams worldwide.

You will mentor colleagues, oversee timelines, and act as the regulatory lead on major projects while building strong relationships with authorities and