Senior Manager, Regulatory Science CMC Complex

McDermott Laboratories Limited Viatris est une entreprise mondiale de la santé idéalement placée pour combler la division traditionnelle entre génériques et marques, combinant le meilleur des deux pour répondre de manière plus globale aux besoins de santé à l'échelle mondiale. Avec pour mission d'autonomiser les personnes du monde entier pour vivre en meilleure santé à chaque étape de la vie, nous offrons un accès à grande échelle, fournissant actuellement des médicaments de haute qualité à environ 1 milliard de patients dans le monde chaque année et touchant tous les moments de la vie, de la naissance à la fin de vie, des affections aiguës aux maladies chroniques. Nous avons été inclus dans plusieurs listes de récompenses qui démontrent l'impact que nous avons. 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 Every day

• 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.

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.

You may just be the right candidate for this or other roles.

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.

Benefits at Viatris

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

• 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

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

Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, perspectives et compétences pour aider à avoir un impact positif sur la vie des autres. Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main d'œuvre mondiale d'environ personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l'être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu'un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d'excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.