Global Regulatory Strategy Director — Hybrid

GlaxoSmithKline; Durham (NC); Híbrido; USD 172.000 - 286.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Health care

Retirement benefits

Paid holidays

Vacation

Paid caregiver/ parental leave

Medical leave

Descripción de la vacante

GlaxoSmithKline seeks an experienced Regulatory Leader to join the Global Regulatory Strategy organization, supporting Respiratory, Immunology and Inflammation portfolios. The role requires driving global/regional regulatory strategies and leading submissions, with accountability across geographies.

You will partner with clinical development, safety, medical, and commercial teams to shape evidence-based approaches and ensure lifecycle regulatory compliance in multiple markets.

Formación

• Bachelor's degree in biological or 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.
• Experience leading regulatory submissions and interactions with health authorities.
• Experience providing regulatory leadership within global, cross-functional matrix teams.
• Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets.

Responsabilidades

• Develop and execute global and regional regulatory strategies for assigned assets.
• Ensure regulatory strategy aligns with development plans and priority markets.
• Provide strategic regulatory leadership to cross-functional teams and coordinate activities.
• Lead health-authority interactions, regulatory submissions, and milestone meetings.
• Translate scientific/regulatory info into clear, actionable recommendations.
• Identify opportunities to strengthen regulatory decision-making using digital approaches.

Conocimientos

Regulatory leadership

Cross-functional leadership

Regulatory strategy

Health authority engagement

Educación

Bachelor's degree in biological/health sciences

Descripción del empleo

GlaxoSmithKline seeks an experienced Regulatory Leader to join the Global Regulatory Strategy organization, supporting Respiratory, Immunology and Inflammation portfolios. The role requires driving global/regional regulatory strategies and leading submissions, with accountability across geographies.

You will partner with clinical development, safety, medical, and commercial teams to shape evidence-based approaches and ensure lifecycle regulatory compliance in multiple markets.