Director, Global Regulatory Affairs Are you passionate about making a difference in global healthcare? At GSK, we are dedicated to improving lives by delivering innovative medicines and vaccines. As a Director of Regulatory Affairs, you will play a pivotal role in shaping regulatory strategies that ensure the availability of safe and effective treatments worldwide. Join us and be part of a team committed to creating healthier communities. Job Purpose Accountable to GRL and Global Regulatory TA Head, the Director of Regulatory Affairs will lead the development of regional and global regulatory strategies and their execution for assigned asset(s) aligned with the overall Medicines Development Strategy. Planning will be on a multi‑year horizon, requiring extensive matrix leadership within GSK to VP level and representing GSK with local regulatory agencies. This role works closely with local and regional commercial teams to secure the best possible labelling commensurate with the available data, and to lead interactions with local and regional regulatory authorities. Key Responsibilities

Ensure the regulatory strategy will deliver the needs of the local region(s), considering the needs of other regions globally. Implement the regional strategy(s) in support of the project globally. Lead regulatory interactions and the review processes in local region. Ensure appropriate interaction with regional commercial teams in local region. Ensure compliance with regional requirements at all stages of product life. Advocate persuasive approaches to senior leaders in GSK and in Health Authorities. Capable of providing assessment of potential in licence molecules.

Why You? Basic Qualifications

Bachelor's degree in Biological or Healthcare Science, with prior experience in similar strategic international regulatory affairs positions. Extensive experience in regulatory affairs across all phases of drug development. Proven track record in leading regional development, submission, and approval activities. Experience working on clinical trial and licensing requirements in major countries.

Preferred Qualifications

PhD in Biological or Healthcare Science. Experience with projects involving little or no precedence in regulatory affairs. Expertise in developing product or therapeutic knowledge in new areas. Familiarity with digitalization in regulatory strategy to enhance decision‑making and innovation. Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance. Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.

Salary and benefits: 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 from $166,650 to $277,750. The US salary ranges take into account location, candidate skills, experience, education level and 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. 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 for a specific country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases—to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note that if your enquiry does not relate to adjustments, we will not be able to support you through these channels. We have created a Recruitment FAQ guide—click the link to find answers to multiple questions. Important notice to Employment businesses/Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of such written authorization, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/. #J-18808-Ljbffr