Global Regulatory Lead, PDx
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Job Description
Global Regulatory Lead overseeing pharmaceutical diagnostics from pre-clinical to registration in global markets. Leading regulatory strategy for new product introductions and compliance obligations.
Responsibilities:
- 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
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