Director, Global Regulatory Strategy

• 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.

• 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.

• 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.

Work Location and Working Style This position is based in the United Kingdom, US, or Belgium and offers a hybrid working model. We encourage a balance of working from our office and remotely, giving you flexibility to manage your work-life needs.

Are you ready to take the lead in regulatory projects that matter? Join us and help shape a healthier future. We welcome your application.

This role provides an opportunity to shape regulatory strategy across the Respiratory, Immunology and Inflammation portfolio and influence the development of medicines from a global perspective. You will work at the centre of multidisciplinary development decisions, engage with health authorities and senior stakeholders, and provide regulatory leadership on scientifically complex programmes.

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Regulatory Strategies, Resource Management, Stakeholder Management

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $171,600 to $286,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Belgium Salary Range / Fourchette salariale - Belgique: EUR 111,750 to EUR 186,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.