Director, Global Regulatory Strategist -Allergy/Cardiovascular portfolio in Hatfield

Director, Global Regulatory Strategist is a senior-level role responsible for leading regulatory strategy for Viatris’ Allergy and Cardiovascular portfolio. The role involves developing globally aligned regulatory plans, managing regulatory submissions, liaising with Health Authorities, collaborating cross-functionally, and ensuring compliance with evolving regulatory standards.

Responsibilities

• Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products.
• Develop and implement regulatory strategies, integrating inputs from regulatory teams and cross‑functional partners to build globally aligned regional regulatory strategies in line with business objectives.
• Manage the preparation and submission of correspondence and applications to regulatory agencies.
• Organize, lead, or participate in meetings with regulatory agencies, ensuring quality expectations are met for all submissions and Health Authority interactions.
• Serve as liaison with Health Authorities, in conjunction with Regulatory Country partners, to facilitate the prompt review and approval of applications, supplements, variations, and commitments.
• Develop global/regional regulatory strategies and implementation plans for Allergy and Cardiovascular complex projects/products, including novel, product enhancement, and post‑approval products.
• Ensure regulatory contributions achieve strategy objectives, meet agreed standards, and optimize overall project delivery time and success probability.
• Provide regulatory input to clinical development programs, risk/benefit assessments, and target label development.
• Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, championing and executing on time to required quality standards.
• Contribute to the development and update of CCDS and local labels as a member of the Product Labelling Team.
• Cultivate sustainable and effective relationships across stakeholders, partners, and customers to drive aligned approaches to regulatory strategies and policies.
• Monitor regulatory plans, communicate progress and risks to Senior Management, and mitigate risks from emerging data, changing objectives, or external impacts.
• Direct activities to ensure required documentation is prepared to high standard and all regulatory requirements and commitments are met for obtaining Marketing Authorisations.
• Draft dossier sections as applicable.
• Work closely with other Regulatory team members to develop and ensure adherence to consistent processes, systems, working practices, shared learnings and quality standards.
• Understand current global and regional evolving regulations and guidelines, assess their impact on products/projects, and use experience to influence the evolving regulatory environment through Health Authority engagement and trade association participation.

Qualifications

• Higher degree (master’s or equivalent) preferred.
• Extensive regulatory experience in a Global Regulatory Affairs Strategy role with hands‑on authoring (initial registrations or post‑approval variations).
• Advanced knowledge of development and commercial activities to assess clinical, scientific and regulatory merits of information, commitments and data, leading teams on complex projects with focus on Allergy and Cardiovascular products.
• Extensive clinical and industry knowledge to shape project strategy, reduce regulatory burden and improve regulatory flexibility across global markets.
• Independent capability in executing all aspects of drug development and commercial manufacturing lifecycle.
• Advanced understanding of current and emerging regulatory requirements & expectations, submission criteria and experience in leading negotiations and interactions with regulatory authorities for projects and policy initiatives.
• Sound understanding of business expectations across partner lines, proven ability to partner successfully with Regulatory functions and other departments (Clinical, Non‑Clinical, Safety, Medical, Commercial, R&D, Legal, senior stakeholders) to achieve objectives.
• Experience in Allergy and Cardiovascular therapeutic areas is an advantage.

Benefits

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

Viatris is an Equal Opportunity Employer. Viatris places a strong emphasis on diversity, inclusion and sustainability.