Senior Manager, Regulatory Science CMC Complex

Biopharma Careers; Ireland; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance

Bonus scheme

Health insurance

Pension

Job summary

McDermott Laboratories Limited, part of Viatris, seeks an experienced Global CMC Regulatory Lead to develop and execute regulatory strategies for complex pharmaceutical products across development and lifecycle.

You will assess regulatory requirements, manage submissions such as new registrations and post-approval changes, and lead cross-functional teams with R&D, Quality, and Regulatory Affairs to ensure timely approvals.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 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.

Responsibilities

• Develop and execute global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management.
• 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 strategies

Global regulatory submissions

Regulatory leadership

Cross-functional collaboration

Project management

Communication

Education

Bachelor's degree in a scientific discipline

Master's degree preferred

Tools

Regulatory document management systems

Microsoft Office

Job description

McDermott Laboratories Limited

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. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

• 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.

About Your Skills & Experience

• 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.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

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. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris 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, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

A t Viatris, we offer competitive salar ies , benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.