Director, Global Regulatory Strategy – Oncology

GlaxoSmithKline; Rockville (MD); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation and caregiver/parental leave

Job summary

GlaxoSmithKline seeks a Director, Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for oncology assets in alignment with development plans and evidence strategies. You will lead or contribute to Regulatory Matrix Team activities and interact with health authorities as needed.

The role requires extensive experience in Regulatory Affairs, cross-functional collaboration, and global regulatory leadership across major markets.

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 the pharmaceutical, biotechnology, or healthcare industry.
• 6+ years supporting drug development programs across multiple phases of clinical development.
• 3+ years developing and executing global regulatory strategies for oncology products.

Responsibilities

• Lead or oversee development and execution of regulatory strategies for assigned assets.
• Provide regulatory leadership for assigned programs and assess regulatory precedent and intelligence.
• Lead interactions with health authorities and regulatory review processes as applicable.
• Collaborate with cross-functional teams to support labeling objectives aligned with data.
• Ensure regulatory activities comply with laws, policies and GSK expectations.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Health authority interactions

Regulatory intelligence

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

GlaxoSmithKline seeks a Director, Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for oncology assets in alignment with development plans and evidence strategies. You will lead or contribute to Regulatory Matrix Team activities and interact with health authorities as needed.

The role requires extensive experience in Regulatory Affairs, cross-functional collaboration, and global regulatory leadership across major markets.