Manager Regulatory CMC Sciences (Injectables)

Viatris; Inverin; On-site; EUR 85,000 - 125,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Senior Regulatory CMC professional to develop global regulatory strategies for injectable products and to guide cross-functional teams through submissions and lifecycle management.

The role requires strong knowledge of US and global regulatory requirements, experience with TrackWise and Documentum, and a proven track record in managing complex CMC programs within a pharmaceutical environment.

Qualifications

• Bachelor's degree (or equivalent) in a science-related discipline.
• Experience in Regulatory Affairs in the pharmaceutical industry.
• Hands-on experience authoring post-approval CMC lifecycle submissions.
• Hands-on Regulatory CMC experience with injectable products.
• Strong knowledge of global regulatory requirements, especially US regulations.
• Experience with injectable/parenteral products submissions.
• Excellent written/verbal communication and regulatory documentation skills.
• Knowledge of cGMP, CFR, USP, Ph. Eur. and FDA guidance.
• Cross-functional collaboration across Regulatory, Manufacturing, Quality, Supply Chain, Commercial and Legal functions.

Responsibilities

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret regulatory requirements and provide risk-based guidance to stakeholders.
• Prepare and analyse global CMC submission documentation and lifecycle activities.
• Support sites with regulatory strategies for variations and supplements.
• Ensure compliance through management of CMC activities and change controls.
• Collaborate with regional teams to support submissions and agency interactions.
• Provide responses to health authority queries and assist in meetings.

Skills

Regulatory strategy

Communication

Cross-functional collaboration

Regulatory documentation

Project management

Team leadership

English technical writing

Education

Bachelor's degree in science

Tools

TrackWise

Documentum

Microsoft Office

Job description

Mylan Teoranta 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 implement global CMC regulatory strategies for injectable products.
• Interpret and communicate regulatory requirements and provide risk-based regulatory guidance to stakeholders.
• Prepare, review and analyse global CMC submission documentation and lifecycle management activities.
• Support manufacturing sites with regulatory strategies and documentation for variations and supplements.
• Ensure regulatory compliance through effective management of CMC activities and change controls.
• Collaborate with regional regulatory, labelling, quality, supply chain and manufacturing teams to support submissions and agency interactions.
• Provide responses to health authority queries and participate in regulatory authority meetings and inspections as required.
• Act as a regulatory subject matter expert within cross-functional project teams.
• Mentor colleagues and contribute to knowledge sharing and capability development.
• Maintain awareness of emerging regulatory requirements and industry trends, communicating impacts to relevant stakeholders.

About Your Skills & Experience

• Bachelor's degree (or equivalent) in a science-related discipline.
• Experience working within Regulatory Affairs in the pharmaceutical industry.
• Hands‑on experience authoring post‑approval CMC lifecycle management submissions.
• Hands‑on Regulatory CMC experience supporting injectable products.
• Strong knowledge of global regulatory requirements, particularly US regulations.
• Experience with injectable, parenteral or combination product submissions.
• Excellent written and verbal communication skills, including preparation and review of regulatory documentation.
• Strong understanding of cGMP requirements, CFR, USP, Ph. Eur. and FDA guidance.
• Experience collaborating across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical and Legal functions.
• Proficiency with Microsoft Office applications and regulatory systems such as TrackWise and Documentum.
• Strong project management skills and the ability to deliver to time, cost and quality standards.
• Previous people management experience would be advantageous.
• TOPRA certification or RAC qualification preferred.

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

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. Some of our benefits include the following on top of a competitive salary:

• 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 exp