Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)

Job Purpose

The Manager / Associate Director ensures the development of appropriate global and regional regulatory strategies and their execution for assigned assets to ensure the development program meets the needs of the key markets identified and the Medicines Profile (and is consistent with the Medicines Development Strategy / Integrated Asset plan). Key to delivery in this role is ensuring compliance with internal GSK process and policies, as well as with appropriate regulatory requirements to deliver the best possible labelling to meet the Medicine Profile (commensurate with the available data).

Key Responsibilities

• Proactively develop regulatory strategies that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
• Implement the regional strategy(s) in support of the project globally.
• Manage regulatory interactions and the review processes in local regions.
• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
• Ensure compliance with global/regional requirements at all stages of product life.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.

About You

This role is a great opportunity to be instrumental in developing and delivering subject matter expertise across GSK. As this role is multi-faceted and includes liaising with a wide variety of key-stakeholders you must have strong experience of working in complex technical situations, with demonstrable clear problem-solving approach to your work. Strong people skills and a proven ability to influence people to achieve and drive performance are also pre-requisites for this role.

Basic Qualifications

• Degree-educated in relevant scientific or technical discipline (or very strong relevant experience).
• Relevant regulatory affairs experience in the EU and/or US and other major markets.
• Experience should include, for example, developing and implementing regional strategies, managing regulatory interactions, submissions, and review processes.
• Clinical regulatory experience is a must, with knowledge of all phases of the drug development process.
• Ability to develop necessary specialist knowledge for the product or area of medicine.
• Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.

Preferred Qualifications

• Experience of all phases of the drug development process in regulatory affairs.
• Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
• Experience in relevant therapy area (especially Immunology & Inflammation) is a plus.

Work Arrangement

This role is hybrid. Regular on-site collaboration is mandatory. Typical schedule will be two to three days on-site per week.