Head of Regulatory Affairs Strategy

Viatris

Dublin or Hatfield

The Role & What You Will Be Doing

The Head of Regulatory Affairs Strategy is a senior level position and will be accountable for the development of regulatory strategies to advance Viatris’ global portfolio of innovative, brand and marketed drugs. 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 regulatory strategies 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 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.