Director at GSK

Job Purpose

Accountable 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. Lead interactions with local / 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 license molecules.

Why You?

Basic Qualifications

• Bachelor’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 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.