Senior Director - Brands Regulatory Affairs

March 6

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Viatris

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Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

Pharmaceuticals • Generics • Anesthesia & Pain Management • CNS • Cardiovascular

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Provide and ensure globally aligned regulatory strategies are in place and implemented for all products in the team’s portfolio. • Development of strategies for growth opportunities and responding to Regulatory agency queries to meet Business priorities. • Accountability for providing strategic regulatory guidance for projects/products. • Collaborate across Global Regulatory Affairs (GRA) to provide global regulatory strategic guidance to stakeholders across the organization. • Work with the policy team to contribute to the development of evolving regulatory guidelines and regulation through Health Authority engagement. • Ensure the impact of new requirements are understood and appropriately managed within the team. • Contribute to the establishment of strong partnerships with project teams and other stakeholders (e.g. Clinical, PSRM, Medical, GCMC, Quality, R&D, Commercial, Legal) for optimal regulatory contributions. • All contributions should meet business needs and quality standards. • Ensure regulatory plans for the team are closely monitored, progress is communicated, and strategies are developed to mitigate any risks. • Lead regulatory Due Diligence activities for business development opportunities. • Directly supervise team of Regulatory Strategists, with responsibility for performance management and support for professional development of staff. • Provide clear leadership and manage workload, ensuring effective prioritization and utilization of resources across the team. • Ensure implementation of consistent quality standards and contribute to appropriate processes and systems for compliance.

🎯 Requirements

• Minimum of a Bachelor's degree (or equivalent) required. • A Doctorate degree (or equivalent) is preferred. • B.S. Scientific Degree required. • An advanced Scientific Degree (Ph.D., PharmD., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential. • Regulatory Affairs educational specialization may be an advantage but is not essential. • However, a combination of experience and/or education will be taken into consideration. • 5 years of Global Regulatory experience is required. • 10 years of US/EU/EM region specific Regulatory experience is required. • 2 years of people management is preferred. • Relevant Global and/or Regional regulatory experience. • In-depth knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation. • Experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management with ability to manage complex regulatory issues. • Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable. • Proven ability to deliver to time, cost, and quality standards. • Proven ability to partner successfully with Regulatory, Commercial, R&D, PSRM, Clinical, Medical and other partner lines to achieve objectives. • Strong leadership experience with an ability to influence within regulatory and across business functions. • Demonstrated commitment to development of others. • Proven ability to successfully communicate and negotiate with major Health Authority(ies). • Strategy development and leadership of interactions and meetings with Health Authorities. • Demonstrated strategic thinking and ability to integrate strategies into actionable plans. • Proven ability to deliver in a highly matrixed organization. • Strong written and verbal communication skills. • Regulatory Affairs Professional Certification is preferred. • Direct supervision of 6-12 professional level employees. • Periodic travel is required. • Proficiency in speaking, comprehending, reading and writing English is required.