Director, Global Regulatory Strategy — Respiratory Assets

GSK

Irvine

On-site

GBP 120,000 - 180,000

Full time

5 days ago

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Job summary

GSK in the United Kingdom is seeking an experienced Director, Global Regulatory Strategy to provide strategic regulatory leadership for Respiratory, Immunology and Inflammation assets across global and regional teams.

You will shape development programmes, align regulatory plans with evidence strategies, lead health-authority interactions, submissions and milestone reviews, and translate complex data into clear guidance for senior leadership.

Qualifications

Bachelor’s degree or equivalent in biological science, healthcare science or related discipline.
Significant regulatory-affairs experience across pharmaceutical development and lifecycle.
Experience developing and delivering regulatory strategies for development programmes.
Experience leading regulatory submission and approval activities.
Track record of leading health-authority interactions.
Experience providing regulatory leadership within global, cross-functional matrix teams.

Responsibilities

Develop and execute global/regional regulatory strategies for Respiratory, Immunology and Inflammation assets.
Ensure regulatory strategy aligns with medicines development plans and priority markets.
Provide strategic regulatory leadership to cross-functional development teams and act as accountability for assets.
Lead health-authority interactions, regulatory submissions, milestone meetings and reviews.
Translate complex regulatory information into clear recommendations for timely decisions.
Lead regulatory matrix teams and coordinate regulatory activities across geographies.