Head of Regulatory Affairs – US & Canada
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $180,000 - $270,000 per year
Job Level
About the role
- Develop and implement regional regulatory strategies to enable timely product approvals and lifecycle management.
- Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development.
- Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries.
- Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies.
- Lead and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high-quality deliverables.
- Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers.
- Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets.
- Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components.
- Experience leading meetings with FDA and Health Canada.
- Background in sterile injectables; radiopharmaceutical experience is a strong asset.
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategiesproduct approvalslifecycle managementregulatory pathwaysCMCQualitynon-clinicalclinical componentssterile injectablesradiopharmaceuticals
Soft skills
leadershipmentoringcollaborationnegotiationprioritizationresource allocationcommunicationproblem-solvingstrategic thinkingcompliance enhancement