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Director, global regulatory strategist

Swords
Bristol Myers Squibb
Director
Posted: 3h ago
Offer description

McDermott Laboratories LimitedAt 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 DoingEvery day, we rise to the challenge to make a difference and here's how the Director, Global Regulatory Strategist role will make an impact.The Director, Global Regulatory Strategist is a senior level position, recognized as an expert for global regulatory strategy in support of the Viatris Allergy/Cardiovascular portfolio.Key responsibilities for this role include:Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned regional regulatory strategies. Strategies should be in alignment with business objectives and key stakeholders/partner lines.Manage the preparation and submission of correspondence and applications to regulatory agencies. Organize, lead, or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions.Direct and/or indirect liaison with Health Authorities (in conjunction with Regulatory Country partners to facilitate the prompt review and approval of applications, supplements/variations, and commitments).Developing Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products including novel, product enhancement and post approval products; Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, while optimizing overall project delivery time and probability of a successful outcome.Providing regulatory input to clit qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Data ProtectionWe will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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