Director

Role Summary

Director, Global Regulatory Affairs responsible for leading the development and execution of regional/global regulatory strategies for assigned assets, aligned with the Medicines Development Strategy. Works with local/regional teams to secure appropriate labeling and leads interactions with regulatory authorities. Requires extensive matrix leadership and representation to local regulatory agencies.

Responsibilities

• Ensure the regulatory strategy delivers 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.

Qualifications

• Required: Bachelor’s degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.
• Required: Extensive experience in regulatory affairs across all phases of drug development.
• Required: Proven track record in leading regional development, submission, and approval activities.
• Required: Experience working on clinical trial and licensing requirements in major countries.
• Preferred: PhD in Biological or Healthcare Science.
• Preferred: Experience with projects involving little or no precedence in regulatory affairs.
• Preferred: Expertise in developing product or therapeutic knowledge in new areas.
• Preferred: Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation.
• Preferred: Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.
• Preferred: Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.

Education

• Bachelor’s degree in Biological or Healthcare Science