Director, Regulatory Affairs

Mylan Institutional 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. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. Every day, we rise to the challenge to make a difference and here’s how role will make an impact: Key responsibilities for this role include: 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 clinical development programs, risk/benefit assessments and for target label development. 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, communicated, and executed on time to the required quality standards. Serving as a member of the Product Labelling Team to contribute to the development and update of the CCDS and contribute to the development and maintenance of local labels, as appropriate. Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies. Ensuring regulatory plans are monitored, progress is communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external impacts) are mitigated. Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author sections of the dossiers, as applicable. Developing and maintaining constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions. Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards. Understanding current global and regional evolving regulations and guidelines with the ability to assess these requirements’ impact on products/projects. Using strong experience and examples, where appropriate, to influence the evolving regulatory environment through Health Authority engagement, partners and trade associations. Supporting regulatory Due Diligence activities for business development opportunities. Provide input to and adhere to departmental budget. The minimum qualifications for this role are: Minimum of a Bachelor’s degree (or equivalent). An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential. A minimum of 8 years in regulatory and a minimum of 5 years of global regulatory experience (US/EU) required. A combination of experience and/or education will be considered. Global Regulatory Affairs strategy, with hand-on authoring experience (initial registrations or post-approval variations) - Minimum of 5+ years Elevated level of knowledge of development & commercial activities to assess clinical, scientific & regulatory merits of information, commitments and data to lead teams and/or complex projects, with a focus on Allergy and Cardiovascular products. Extensive clinical and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle. Knowledge of Global applications for applications for Allergy and Cardiovascular products and product development an advantage. Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives. Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Clinical, Non-Clinical, Safety, Medical, Commercial, R&D, Legal and senior stakeholders to achieve objectives. Allergy and Cardiovascular therapeutic areas an advantage. Advanced skills in written & oral communications (mandatory). Computer literacy with Microsoft Office Suite and Documentum-based applications. Prior experience (minimum of 5+ years) managing projects and matrixed teams and/or serving as a people manager. Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel. Demonstrated commitment and dedication to scientific and regulatory integrity. Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other partner lines and senior stakeholders to achieve objectives. Proven ability to deliver to time, cost and quality standards. Demonstrated strategic thinking and ability to integrate strategies into actionable plans. With a strong track record of demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role to be assumed which requires minimal supervision. As an individual contributor: Position functions autonomously, with minimal supervision. Regulatory Affairs Professional Certification, preferred. Ability to read and interpret comprehensive and intricate research documents. Ability to author scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization. Typically sitting at a desk or table. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary – Minimal handling of light materials, lifting up to 10 lbs. Periodic travel may be required. Normal office situation 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 $112,000 - $236,000 USD. 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. #J-18808-Ljbffr