Global Oncology Regulatory Strategy Director

GlaxoSmithKline plc; Durham (CA); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Health care benefits

Retirement benefits

Paid holidays

Vacation

Job summary

GlaxoSmithKline is seeking a Director of Global Regulatory Strategy- Oncology to lead regulatory strategies for assets, aligning with development plans and evidence strategies. Role includes potential people leadership and global regulatory lead responsibilities for assigned assets.

Hybrid work in the US with leadership activities on-site; experience leading health authority interactions and cross-functional collaboration is required for success in this position.

Qualifications

• Bachelor’s degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
• 8+ years of experience in Regulatory Affairs within pharma/biotech/healthcare.
• 6+ years of experience supporting drug development programs across phases.
• 3+ years of experience developing and executing global regulatory strategies for Oncology products.

Responsibilities

• Lead or oversee development and execution of regulatory strategies for assets.
• Provide regulatory leadership including regulatory precedent and intelligence assessments.
• Lead or contribute to interactions with health authorities and regulatory review processes.
• Collaborate with Early Development, Medicine Development, local regulatory teams, and cross-functional partners.
• Ensure activities comply with laws, regulations, and internal policies.
• Input into due diligence, BD, or portfolio-level assessments as needed.
• Mentor and develop regulatory staff where applicable.
• Support program-level strategy and resource planning.
• Communicate regulatory risks and options to senior leaders.

Skills

Regulatory Strategy

Regulatory Leadership

Cross-functional Collaboration

Stakeholder Management

Education

Bachelor's degree in biology or related field

Advanced degree (MS/PhD/MD/PharmD) preferred

Job description

GlaxoSmithKline is seeking a Director of Global Regulatory Strategy- Oncology to lead regulatory strategies for assets, aligning with development plans and evidence strategies. Role includes potential people leadership and global regulatory lead responsibilities for assigned assets.

Hybrid work in the US with leadership activities on-site; experience leading health authority interactions and cross-functional collaboration is required for success in this position.