Manager, Brands Regulatory CMC Sciences at Viatris in Dublin

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 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