Director, Global Regulatory Strategy

Position Summary

We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory, Immunology and Inflammation portfolio. As Director, Global Regulatory Strategy, you will provide strategic regulatory leadership for assigned assets, working across global and regional teams to shape development programmes and deliver effective regulatory strategies. You will operate as a senior individual contributor, bringing regulatory insight, scientific understanding and sound judgement to complex development decisions. Depending on portfolio needs, you may serve as Global Regulatory Lead or Regional Regulatory Director for selected assets, leading regulatory strategy and engagement with health authorities throughout development and the product lifecycle.

What you'll do

• Develop and execute innovative, evidence-based global and regional regulatory strategies for assigned Respiratory, Immunology and Inflammation assets.
• Ensure regulatory strategy is integrated with medicines development plans, evidence-generation strategies and the requirements of priority markets.
• Provide strategic regulatory leadership to cross-functional development teams and act as a key point of accountability for assigned assets.
• Assess regulatory precedent, intelligence and the competitive environment to identify opportunities, risks and implications for development strategy.
• Translate complex scientific and regulatory information into clear recommendations that enable timely, well-informed decisions.
• Lead regulatory matrix teams and coordinate delivery of regulatory activities across functions and geographies.
• Lead health-authority interactions, regulatory submissions, milestone meetings and review processes.
• Partner effectively with clinical development, safety, medical, commercial and local regulatory colleagues.
• Develop regulatory approaches that support appropriate labelling based on the available evidence and applicable regulatory requirements.
• Anticipate regulatory risks and develop practical strategies to address them.
• Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
• Represent regulatory perspectives with senior leaders and health authorities, advocating clearly and credibly for evidence-based approaches.
• Contribute regulatory expertise to due-diligence and business-development activities where required.
• Identify opportunities to use digital capabilities and new approaches to strengthen regulatory decision-making and improve efficiency.

Basic qualifications and experience

• A bachelor's degree or equivalent relevant professional experience in biological science, healthcare science or a related discipline.
• Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle.
• Experience developing and delivering regulatory strategies for development programmes.
• Experience leading regulatory submission and approval activities.
• A track record of leading interactions or milestone meetings with health authorities.
• Experience providing regulatory leadership within global, cross-functional matrix teams.
• Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets, together with a sound understanding of the global regulatory environment.

Preferred qualifications and experience

• A master's degree, PhD or other advanced scientific or regulatory qualification.
• Regulatory experience supporting Respiratory, Immunology and Inflammation medicines or development programmes.
• Experience acting as a Global Regulatory Lead, Regional Regulatory Director or in a comparable strategic regulatory role.
• Experience leading regulatory activities across multiple geographic regions.
• Experience working across different stages of development, from early development through registration and lifecycle management.
• Experience leading regulatory strategy where there is limited precedent or significant scientific complexity.
• Strong influencing and communication skills, including the ability to make complex regulatory issues clear to different audiences.
• Demonstrated ability to build effective relationships and influence decisions without formal authority.
• A strong commitment to quality, ethical conduct and compliance with applicable laws, regulations and company requirements.
• Strong clinical and scientific understanding of drug development.
• Experience applying regulatory intelligence, data or digital approaches to development and regulatory decision-making.
• Experience providing regulatory input to due diligence, licensing or business-development evaluations.