Global Regulatory Affairs Portfolio Lead, Marketed Products, Radiopharma

GE HealthCare · Remote

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Role summary

GE HealthCare seeks a Global Regulatory Affairs Portfolio Lead to oversee registration and lifecycle management of marketed radiopharmaceutical products. The role involves providing regulatory strategy, cross-functional leadership, and agency engagement to maintain compliance and optimize the product portfolio.

What they're looking for

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field
Extensive regulatory affairs experience with post-approval lifecycle management focus
Proven cross-functional global team collaboration and project management skills
Experience interfacing with international regulatory agencies
Strong communication and prioritization capabilities
Radiopharmaceutical sector regulatory experience preferred

What you'll be doing

Oversee regulatory activities including variations, renewals, and regulatory commitments for assigned portfolio
Provide strategic regulatory input on commercial plans and notify leadership of significant submission status and business risks
Lead regulatory agency meetings and coordinate globally aligned regional regulatory strategies
Build stakeholder networks and interpret external regulatory environment to optimize portfolio continuously
Plan regulatory budget and ensure regional regulatory needs are incorporated into global strategies

Compensation$132,000-$198,000 base annual, plus performance-based incentives

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