Global Regulatory Strategy Leader — Respiratory Immunology

GlaxoSmithKline; Rockville (MD); Hybride; USD 172 000 - 286 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement benefits

Paid time off

Résumé du poste

GlaxoSmithKline is seeking an experienced Regulatory Leader to join Global Regulatory Strategy, supporting Respiratory, Immunology and Inflammation assets. You will develop and execute global regulatory strategies and provide leadership to cross-functional teams.

You will lead health-authority interactions, regulatory submissions, and strategic development plans while ensuring lifecycle compliance across regions. Hybrid work options available, with global scope and complex programmes.

Qualifications

• Bachelor's degree or equivalent in biological science, 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 submission and approval activities.
• Track record of leading health-authority interactions or milestone meetings.
• Experience providing regulatory leadership within global, cross-functional matrix teams.
• Strong knowledge of clinical-trial and marketing-authorisation requirements in major markets and a global regulatory environment.

Responsabilités

• Develop and execute global and regional regulatory strategies for assigned assets.
• Ensure regulatory strategy aligns with medicines development plans and priority markets.
• Provide strategic regulatory leadership to cross-functional teams and be accountable for assigned assets.
• Assess regulatory precedent, intelligence and competition to inform strategy.
• Lead regulatory matrix teams and coordinate regulatory activities across functions and geographies.
• Lead health-authority interactions, submissions and milestone meetings.

Connaissances

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Policy Advocacy

Regulatory Strategies

Resource Management

Stakeholder Management

Formation

Bachelor's degree or equivalent in biological/healthcare sciences

Master's degree or PhD (advanced qualification)

Description du poste

GlaxoSmithKline is seeking an experienced Regulatory Leader to join Global Regulatory Strategy, supporting Respiratory, Immunology and Inflammation assets. You will develop and execute global regulatory strategies and provide leadership to cross-functional teams.

You will lead health-authority interactions, regulatory submissions, and strategic development plans while ensuring lifecycle compliance across regions. Hybrid work options available, with global scope and complex programmes.