Global Regulatory Strategy Director: Respiratory & Immunology

Regulatory Jobs; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

GSK seeks an experienced regulatory leader to join Global Regulatory Strategy, supporting Respiratory, Immunology and Inflammation assets. You will provide strategic regulatory leadership for assets, engaging with global and regional teams to shape development programmes and regulatory strategies.

You may serve as Global Regulatory Lead or Regional Regulatory Director, leading strategy and engagement with health authorities across the product lifecycle.

Qualifications

• Bachelor's degree or equivalent in biological/healthcare science or related discipline.
• Significant regulatory-affairs experience across pharmaceutical development and the product lifecycle.
• Experience developing and delivering regulatory strategies for development programmes.

Responsibilities

• Develop and execute global and regional regulatory strategies for Respiratory, Immunology and Inflammation assets.
• Integrate regulatory strategy with medicines development plans and market requirements.
• Provide strategic regulatory leadership to cross-functional development teams.
• Lead health-authority interactions, regulatory submissions, and milestone meetings.
• Collaborate with clinical development, safety, medical, commercial and local regulatory colleagues.

Skills

Regulatory strategy

Leadership

Cross-functional teams

Regulatory submissions

Education

Bachelor's degree in biological/healthcare science

Job description

GSK seeks an experienced regulatory leader to join Global Regulatory Strategy, supporting Respiratory, Immunology and Inflammation assets. You will provide strategic regulatory leadership for assets, engaging with global and regional teams to shape development programmes and regulatory strategies.

You may serve as Global Regulatory Lead or Regional Regulatory Director, leading strategy and engagement with health authorities across the product lifecycle.