Head of Global Regulatory Affairs Strategy - Global Regulatory Affairs

McDermott Laboratories Limited

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.
 

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 Doing

The Head of Global Regulatory Affairs Strategy is a senior-level position and will be accountable for the development of regulatory strategies to advance Viatris’ global portfolio of complex, value-add, and innovative products. This individual will provide strategic direction throughout the development and post-approval life cycle of our portfolio, driving engagement with global health authorities to develop and define, specifically in the area of regulatory strategy​ , ​that will enable approval of new products aligned with the company’s plans. This leader will play a key role in developing and communicating strategic vision, assuring regulatory compliance, setting priorities, and working with internal and external partners to influence business decisions and priorities. The role demands clear leadership with excellent communication and stakeholder management.

Every day, we rise to the challenge to make a difference and here’s how the Head of Global Regulatory Affairs Strategy role will make an impact.

Key responsibilities for this role include:

• Provides leadership, strategic direction, and managerial oversight to the Viatris Global Regulatory Strategy team, to ensure timely and successful submissions of drug applications to global regulatory agencies that will enable timely approval.

• Establishes and implements strong partnerships with Global, Regional, and Local stakeholders from cross-functional disciplines (e.g., R&D, Quality, Technical Services, Operations, Commercial & Medical) to foster the development and implementation of strategies which expedite the registration of new products, line extensions, and post-approval and life-cycle maintenance changes via risk identification and mitigation.

• Provides input into new business development opportunities.

• Assures coordination and implementation of consistent standards and process throughout the Global Strategic regulatory teams, and establishes alignment with regulatory processes/principles, global policies & regulations, and corporate leadership priorities and values.

• Establishes team objectives and operational/strategic plans that are aligned to the strategic direction and vision of the Global Regulatory Affairs team and those of other key stakeholders (R&D, Drug Safety, Clinical, Operations, Commercial and Medical).

• Supports the development and maintenance of excellent relationships with global regulatory agencies to influence future regulations and to problem solve specific project/compound/product issues.

• Supports Regulatory Affairs partners in the development and maintenance of local regulatory agency relationships.

• Partners with corporate affairs, government affairs, and other local policy leaders to achieve business policy objectives.

• Establishes/defines the roles and required competencies of the Global Strategy team and implements strategies to enhance capacity and capabilities.

• Works with regulatory colleagues across business functions to develop and strengthen relationships, harmonize practices, and deliver a single One-Viatris voice.

• Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.

• Directs/provides opportunities including training/rotational development, professional growth, and development of the global strategy team.

• Provides oversight and direction respecting performance management, talent acquisition, and succession planning.

About Your Skills & Experience

• A higher degree (MS, PhD, PharmD, MBA) is preferred.

• Extensive global regulatory leadership experience is required along with experience in a relevant technical field (e.g. R&D, Clinical, Quality, Technical Services).

• Demonstrable strategic experience across the drug development and commercial lifecycle, with proven examples of contribution.

• Experience with innovative, branded products and generic drug regulatory submissions and approvals, drug master files (DMFs), Certificate of Suitability (CEP) filings, and contribution to the development of global compendial requirements.

• Experience with diverse dosage forms, including sterile products and drug-device combination products is desirable.

• Global regulatory experience including thorough knowledge of strategy aspects of clinical trials, new product submission processes and product life cycle management activities.

• Line management and leadership experience at a senior management level is essential.

• Demonstrable experience of effective delivery in a complex matrix environment.

• Knowledge of global policies, regulations, and guidelines, with extensive technical, functional and industry knowledge in shaping project strategies, reducing regulatory burden and improving regulatory flexibility across global markets and diverse therapeutic areas.

• 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, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal, and senior stakeholders to achieve objectives.

Benefits at Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offercompetitivesalaries, benefitsandan 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.