GSK

Manager, Global Regulatory Affairs – Oncology

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Upper Providence • Maryland • Massachusetts • United States

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Salary

💰 $138,750 - $231,250 per year

Job Level

Junior

About the role

  • Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
  • Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
  • Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
  • Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.

Requirements

  • Minimum of a Bachelor’s degree in biological or healthcare science.
  • Minimum of 1 year experience in the drug development process within regulatory affairs.
  • Proven ability to manage development, submission, and approval activities in different regions globally.
  • Minimum of one year of experience in clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.
  • Advanced Scientific Degree (PhD, MD, PharmD) is preferred.
  • Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs is preferred.
Benefits
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Paid caregiver/parental and medical leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategiesclinical trial applicationsdrug development processsubmission activitiesapproval activitiesclinical trial requirementsregulatory intelligenceOncology regulatory affairsHematologySolid Tumor
Soft Skills
effective interactioncross-functional teamworkcommunicationstrategic assessmentproblem-solving
Certifications
Bachelor’s degreePhDMDPharmD