Global Regulatory Strategy Leader (Hybrid)

GlaxoSmithKline; Waltham (MA); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Long-term incentive program

Health and retirement benefits

Job summary

GlaxoSmithKline seeks an experienced regulatory leader to join our Global Regulatory Strategy group, supporting Respiratory, Immunology and Inflammation assets. You will shape global/regional regulatory strategies and lead cross-functional teams to deliver timely submissions.

Based in a flexible hybrid model (UK/US/Belgium options), you will interact with health authorities, manage milestones, and translate complex science into actionable regulatory plans, influencing lifecycle decisions and

Qualifications

• Bachelor's degree or equivalent in biological/health sciences 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 interactions with health authorities.

Responsibilities

• Develop and execute global and regional regulatory strategies for assigned assets.
• Integrate regulatory strategy with development plans and market requirements.
• Provide strategic regulatory leadership to cross-functional teams.
• Assess regulatory precedent and competitive environment for strategy.
• Translate complex regulatory information into clear recommendations.
• Lead regulatory matrix teams and coordinate activities across functions.
• Lead health-authority interactions, submissions and milestone meetings.
• Partner with clinical development, safety and commercial teams.
• Develop regulatory approaches for labeling based on evidence and requirements.
• Anticipate risks and develop practical strategies to address them.
• Ensure regulatory compliance throughout product lifecycle.
• Represent regulatory perspectives with senior leaders and authorities.
• Contribute regulatory input to due diligence and business development.

Skills

Regulatory leadership

Cross-functional leadership

Regulatory strategy

Health-authority interactions

Regulatory submissions

Communication skills

Influencing without authority

Education

Bachelor's degree or equivalent in biological/health sciences

Master's degree or PhD in regulation/science

Job description

GlaxoSmithKline seeks an experienced regulatory leader to join our Global Regulatory Strategy group, supporting Respiratory, Immunology and Inflammation assets. You will shape global/regional regulatory strategies and lead cross-functional teams to deliver timely submissions.

Based in a flexible hybrid model (UK/US/Belgium options), you will interact with health authorities, manage milestones, and translate complex science into actionable regulatory plans, influencing lifecycle decisions and