Director, Regulatory Strategist

Benefits

Additional Information

Mylan Inc. 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. Every day, we rise to the challenge to make a difference and here's how the Director, Regulatory Strategist role will make an impact: Developing Global/Regional regulatory strategies and implementation plans for 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. Partnering with project teams and other stakeholders (e.g. Clinical, Safety, Medical, GCMC, Quality, R&D, Commercial, Legal) to ensure required regulatory contributions (briefing documents, Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and quality standards and are provided in accordance with agreed timelines. Providing regulatory input to clinical development programs, risk/benefit assessments and for target label development. Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and provide strategic input to the development and maintenance of labels as appropriate. Ensuring regulatory plans are monitored, progress is communicated to Senior leadership and any risks (from emerging technical data, changing internal objectives or external impacts) are clearly communicated and mitigated where possible. Developing fit-for-purpose submission packages in collaboration with partner lines. Ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining and maintaining Marketing Authorizations. Author sections of the dossiers, as applicable. Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions are championed and executed on time and to the required quality standards. Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Supporting regulatory Due Diligence activities for business development opportunities. Working closely with other Regulatory team members to develop and ensure adherence to processes, systems, working practices, shared learnings and quality standards. Implementing systems, processes and procedures relating to regulatory productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines. Enhanced understanding of current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, Country Office partners and trade associations. Ensuring business compliance and implementation of and adherence to regulatory standards. The minimum qualifications for this role are: B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) preferred. Minimum 8 years of US,EU,EM Regulatory experience required. Minimum 5 years of Global Regulatory experience preferred . However, a combination of experience and/or education will be taken into consideration. Relevant Global and/or Regional regulatory experience. Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation. Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management including 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, Safety, Medical, other partner lines and senior stakeholders to achieve objectives. Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions. Demonstrated strategic thinking and ability to integrate stra

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