Global Oncology Regulatory Strategy Lead

GSK; Durham (NC); On-site; USD 139,000 - 231,000; Full time

Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Paid leave

Job summary

GSK in Durham, NC is seeking a Regulatory Affairs professional to drive regulatory strategy for clinical trial applications and ensure timely submissions. The role requires collaboration with cross-functional teams across regions and strong attention to compliance during the product lifecycle.

The candidate will contribute to oncology drug development and regulatory submissions, leveraging experience in matrix environments and a solid life sciences foundation.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, medicine or related field.
• 1+ years of experience in the drug development process within regulatory affairs.
• Experience with oncology drug development, including clinical trial applications and regulatory submissions.
• Experience working in matrix teams across functions and regions.

Responsibilities

• Regulatory Strategy: Develop or implement regulatory strategies for submissions within timelines.
• Cross-functional Collaboration: Interact with cross-functional teams, global/regional counterparts, and local operating companies.
• Compliance: Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
• Regulatory Intelligence: Assess precedent, regulatory intelligence, and the competitive environment to inform strategies.

Skills

Bachelor's degree

1+ year experience

Oncology drug development

Matrix cross-functional teamwork

Education

Bachelor's degree in life sciences/pharmacy/medicine

Advanced Scientific Degree (PhD/MD/PharmD)

Job description

GSK in Durham, NC is seeking a Regulatory Affairs professional to drive regulatory strategy for clinical trial applications and ensure timely submissions. The role requires collaboration with cross-functional teams across regions and strong attention to compliance during the product lifecycle.

The candidate will contribute to oncology drug development and regulatory submissions, leveraging experience in matrix environments and a solid life sciences foundation.