Global Regulatory Lead, PDx
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $153,600 - $230,400 per year
Job Level
About the role
- Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness
- Working with NRA, ensure timely GRA input to global development programs
- For assigned programs/projects, identify regulatory opportunities, potential risks, and mitigations
- Guide, influence and motivate, internal and external stakeholders to meet GE HealthCare business and development project team objectives
- Fulfillment of RA compliance obligations
Requirements
- Bachelor’s Degree in Science, Biotech, Engineering or related field
- 7+ years of experience in regulatory, preferably in the pharmaceutical field
- Proven track record of leading successful US NDA/BLA licensing submissions and Pan European (CP, DCP, MRP), European national
- Proven track record of leading successful interaction with regulatory agencies and relevant stakeholders
- Proven expertise with clinical related regulations/guidance as it relates to development of product submissions
- Ability to clearly convey and exchange information with internal and external stakeholders
Benefits
- medical
- dental
- vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life
- disability
- accident insurance
- tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyregulatory submission readinessNDA licensing submissionsBLA licensing submissionsCPDCPMRPclinical regulationsproduct submissions
Soft Skills
leadershipinfluencemotivationcommunicationstakeholder engagement
Certifications
Bachelor’s Degree in ScienceBachelor’s Degree in BiotechBachelor’s Degree in Engineering