Manager, Brands Regulatory CMC Sciences

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.

This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.

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, we rise to the challenge to make a difference, and here’s how the Manager, Brands Regulatory CMC Sciences role will make an impact:

This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business.

·       Ensure regulatory conformance and consistency globally and in compliance with external regulatory requirements and internal quality procedures.

·       Demonstrate regulatory knowledge and experience, balanced judgment, crisp decision-making, exemplary collaboration and business acumen, i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy and quality standards

·       Develop robust regulatory strategies, leveraging both technical and regulatory knowledge, to mitigate risks.

·       Prepare and deliver high-quality CMC regulatory submissions & submission management plans for global regulatory agencies.

·       Execute using regulatory policies and operational processes for delivering the product portfolio.

·       Serve 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 for specific projects/products/markets with minimal supervision.

·       Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.

·       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.

·       Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.

·       Prioritize and independently complete assigned workload appropriately.

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

·       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.

·       Manage and contribute to CMC-related projects, initiatives and actions.

·       Participate, as required, in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

·       Mentor colleagues within focused area of expertise.

·       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:

KNOWLEDGE

Must possess knowledge of:

·       Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) - Minimum of 2+ years

·       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 to lead teams and/or project(s).

·       Technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.

·       Regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.

·       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.

·       Sound understanding of business expectations across divisions

·       Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.

SKILLS AND ABILITIES

Must possess:

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

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

·       Prior experience managing projects.

·       Ability to participate in limited interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.

·       Ability to demonstrate commitment and dedication to scientific and regulatory integrity and quality compliance.

·       Ability to engage in the external regulatory and pharmaceutical environment.

·       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

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.