Head of Regulatory Affairs Strategy

McDermott Laboratories Limited

Overview

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, Viatris provides 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. Viatris is committed to education, outreach and better access to treatment and fosters a collaborative culture that encourages courage and resilience.

The Head of Regulatory Affairs Strategy is a senior level position responsible for developing regulatory strategies to advance Viatris’ global portfolio of innovative, brand and marketed drugs. This role provides strategic direction across development and post-approval life-cycle, engages with global health authorities to define regulatory strategies that enable product approvals aligned with company plans, and communicates a strategic vision while ensuring regulatory compliance and priority setting.

Key responsibilities and expectations are described below.

Responsibilities

• 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 enable timely approval.
• Establishes and maintains strong partnerships with Global, Regional, and Local stakeholders from cross-functional disciplines to foster development and implementation of strategies that expedite registration of new products, line extensions, and post-approval and lifecycle maintenance changes through risk identification and mitigation.
• Provides input into new business development opportunities.
• Ensures coordination and implementation of consistent standards and processes across Global Strategic regulatory teams, aligning with regulatory processes, global policies, regulations, and leadership priorities.
• Sets team objectives and operational/strategic plans aligned to the Global Regulatory Affairs direction and other key stakeholders (R&D, Drug Safety, Clinical, Operations, Commercial and Medical).
• Supports development and maintenance of excellent relationships with global regulatory agencies to influence future regulations and resolve project/compound/product issues.
• Supports Regulatory Affairs partners in developing and maintaining local regulatory agency relationships.
• Partners with corporate affairs, government affairs, and other local policy leaders to achieve business policy objectives.
• Defines roles and competencies of the Global Strategy team and implements strategies to enhance capacity and capabilities.
• Collaborates with regulatory colleagues across functions to harmonize practices and deliver a unified Viatris voice.
• Drives continuous improvement in regulatory processes, systems, and capabilities.
• Directs opportunities including training, rotational development, and succession planning for the global strategy team.

Qualifications

• A higher degree (MS, PhD, PharmD, MBA) is preferred.
• Extensive global regulatory leadership experience, 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 contributions.
• Experience with innovative, branded products and generic drug regulatory submissions and approvals, DMFs, CEP filings, and development of global compendial requirements.
• Experience with diverse dosage forms, including sterile products and drug-device combination products is desirable.
• Global regulatory experience including knowledge of clinical trials strategy, new product submission processes and lifecycle management.
• Line management and senior leadership experience.
• Proven ability to deliver effectively in a complex matrix environment.
• Knowledge of global policies, regulations, and guidelines with extensive technical and industry knowledge to shape project strategies and reduce regulatory burden across markets.
• Understanding of current and emerging regulatory requirements and ability to lead negotiations with regulatory authorities for projects and policy initiatives.
• Ability to collaborate with Regulatory, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.

Benefits

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity, Inclusion & Sustainability

Viatris values diversity and inclusion as essential to its mission and fosters diversity, equity and inclusion across the business. For more information about diversity and inclusion, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion. Corporate social responsibility is foundational to Viatris, with ongoing efforts in responsible and sustainable operations. For more information, please visit https://www.viatris.com/en/about-us/corporate-responsibility.

Viatris is an Equal Opportunity Employer.

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