Reference #: R56190663850 Upjohn US 2 LLC

　　At 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.

　　Every day, we rise to the challenge to make a difference and here's how the role will make an impact:

　　Key responsibilities for this role include:

　　Developing or contributing to Global/Regional regulatory strategies and implementation plans developed for assigned projects/products., Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, and minimize resource demands while optimizing overall project delivery time and probability of success and facilitating post-filing activities.

　　Partnering with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, Supply, etc.) to ensure required regulatory contributions (,briefing documents, Global Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and are provided to the project teams, in accordance with agreed time, cost and quality standards.

　　Developing and maintaining constructive working relationships with Health Authority contacts.

　　Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.

　　Ensuring regulatory plans are monitored, progress/variance is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) is mitigated

　　Developing fit-for-purpose submission packages in collaboration with partner lines

　　Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed and communicated.

　　Working closely with other Regulatory Strategists and CMC Team within and across clusters/TAs and sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

　　Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.

　　Engaging in appropriate activities in order to influence the regulatory environment through Health Authority contacts, Country Office partners and trade associations as appropriate.

　　The minimum qualifications for this role are:

　　Bachelor's degree required. Doctorate degree preferred. Specialization in the scientific area required.

　　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.

　　5 years of US Regulatory experience required. 3 years Global regulatory experience preferred.

　　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, Safety, Medical and other partner lines to achieve objectives

　　Proven ability to successfully communica e and negotiate with major Health Authority(ies), including leading and participating in such interactions

　　Knowledge of assigned therapeutic areas/disease areas is preferred

　　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 skillsAbility to work independently with minimum supervision

　　Sedentary - Minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.

　　Proficiency in speaking, comprehending, reading and writing English is required.

　　Exact compensation may vary based on skills, experience, and location. The salary range for this position is $96,000-$187,000.

　　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.

　　Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

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　　Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â