Global Oncology Regulatory Strategy Leader

GSK; United States; Ibrido; USD 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

GSK is seeking a Director, Global Regulatory Strategy- Oncology in the United States. You will develop and execute regulatory strategies for oncology assets, ensuring alignment with development plans, market needs, and regulatory requirements.

You will lead interactions with health authorities and coordinate cross-functional teams globally to drive strategy and approvals. The role may involve people leadership and Global Regulatory Lead responsibilities for multiple assets, with a hybrid work

Competenze

• Bachelor's degree in biology or related field.
• 8+ years in Regulatory Affairs in pharma/biotech/healthcare.
• 6+ years supporting multi-phase drug development.
• 3+ years building global regulatory strategies in Oncology.
• Experience leading Health Authority interactions.
• Cross-functional development team experience (Clinical, Safety, Commercial, Stats, CMC).
• Experience in major markets including US/EU and other jurisdictions.
• Ability to influence senior stakeholders in a matrix environment.

Mansioni

• Lead or oversee development and execution of regulatory strategies for assets; align with development plans.
• Provide regulatory leadership on precedent, intelligence, and landscape impacts on asset strategy.
• Lead/coordinate interactions with health authorities and regulatory review processes.
• Collaborate with Early Development, Medicine Development, local regulatory, commercial partners, and other stakeholders.
• Act as accountable for regulatory work packages and participate in Regulatory Matrix Team activities.
• Ensure activities comply with laws, policies, and GSK expectations.
• Contribute to due diligence, business development, or portfolio assessments as needed.
• Manage and develop teams where leadership is part of the role; workforce planning and resource management.

Conoscenze

Regulatory strategy

Leadership

Cross-functional teams

Regulatory intelligence

Global regulatory

Formazione

Bachelor's degree in Life Sciences

Descrizione del lavoro

GSK is seeking a Director, Global Regulatory Strategy- Oncology in the United States. You will develop and execute regulatory strategies for oncology assets, ensuring alignment with development plans, market needs, and regulatory requirements.

You will lead interactions with health authorities and coordinate cross-functional teams globally to drive strategy and approvals. The role may involve people leadership and Global Regulatory Lead responsibilities for multiple assets, with a hybrid work