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Global Regulatory Lead
GE HealthCareGlobal Regulatory Lead responsible for regulatory strategy and compliance in pharmaceutical diagnostics development. Leading submissions and interactions with regulatory agencies for new product introductions.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life insurance
- Disability insurance
- Accident insurance
- Tuition reimbursement
ATS Keywords
✓ Tailor your resumeApplicant 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