Global Regulatory Strategy Lead

Biopharma Careers

Durham (NC)

On-site

USD 139,000 - 231,000

Full time

14 days+

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Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Vacation

Caregiver/Parental leave

Medical leave

Job summary

GSK is seeking a Regulatory Affairs professional to lead regulatory strategies for clinical trial applications and submissions across the US. You will work within matrix teams across functions and regions to drive oncology drug development and ensure timely approvals.

The role emphasizes proactive problem solving, advanced scientific knowledge, and alignment with global regulatory requirements. Competitive salary, bonus eligibility, and comprehensive benefits are offered.

Qualifications

Bachelor’s degree in life sciences, pharmacy, medicine, or related field.
1+ year of experience in drug development within regulatory affairs.
Experience with oncology drug development and regulatory submissions.
Experience working in matrix teams across functions and regions.
PhD/MD/PharmD (preferred)

Responsibilities

Regulatory strategy: develop or implement regulatory strategies for submissions.
Cross-functional collaboration with global/regional teams and local operating companies.
Ensure compliance with global and regional regulatory requirements throughout product lifecycle.
Regulatory intelligence: assess precedent and regulatory intelligence to inform strategies.