Assistant Manager, Regulatory Affairs CMC (Global)

McDermott Laboratories Limited

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
Partnership – Leveraging our collective expertise to connect people to products and services. 
 

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

The Assistant Manager, Regulatory Affairs Global CMC possesses CMC regulatory knowledge and quality expertise to prepare regulatory assessments and contribute to global regulatory strategies (with some supervision) for projects across all aspects of drug development or manufacturing lifecycle and works in support of the Branded products portfolio.

Every day, we rise to the challenge to make a difference and here’s how the Assistant Manager, Regulatory Affairs Global CMC role will make an impact:

• Author and/or coordinate CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinate and contribute to responses to Agency queries and perform quality review of regulatory CMC submissions.

• Ensure delivery of high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies and timelines.

• May serve or contribute as CMC representative on a core project(s), manage project activities, assess regulatory risks and develop plans to develop global regulatory strategies for programs in accordance with regulatory, scientific and technical criteria.

• Manage regulatory issues, maintain submission information in relevant CMC systems, track regulatory commitments & timelines, and manage priorities for specific projects/products/markets with minimal supervision.

• Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, and peer review of CMC submissions as required.

• Develop effective relationships with local and global internal partners, i.e., CMC Product Leads; R&D; Quality; Global, Country & Regional Regulatory Leads, and Regulatory Operations.

• Execute training related activities (e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums and learning opportunities, engage in Straight Talk and Listen exchanges, demonstrate and model adherence to all Viatris’ behaviors and values, embrace and comply with Principles of Integrity.

• Perform other duties as assigned.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)

• Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data. 

• Updating, interpreting, and applying global and regional CMC guidelines, along with the ability to contribute to global regulatory strategies by proactively discussing with partners.

• Emerging awareness of new scientific or manufacturing technology.

• An understanding and working knowledge of the of global regulatory requirements & expectations and experience interacting with development & manufacturing operations teams.

• Demonstrated commitment & dedication to scientific and regulatory integrity and quality & compliance.

• Advanced skills in written & oral communications (mandatory).

• Computer literacy with Microsoft Office Suite and Documentum-based applications.

• Ability to serve as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains.

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.

Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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

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. 

Viatris is an Equal Opportunity Employer.