Director

Director, Global Regulatory AffairsAre 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 PurposeAccountable to GRL and Global Regulatory TA Head, the Director of Regulatory Affairs will lead the development of regional / global regulatory strategies and their execution for assigned asset(s) aligned with the overall Medicines Development Strategy. Planning will be on a multiple year horizon, with delivery requiring extensive matrix leadership within GSK to VP level and representing GSK with local regulatory agency. This role works closely with local / regional commercial teams to secure best possible labelling commensurate with the available data and lead interactions with local / regional regulatory authorities.Key ResponsibilitiesEnsure 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 license molecules.Basic QualificationsBachelor’s degree in Biological or Healthcare Science, with previous 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 QualificationsPhD 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.Why GSK?Uniting science, technology and talent to get ahead of disease together. 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.Contacts & AdjustmentsIf you require adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at J-18808-Ljbffr#J-18808-Ljbffr