Director, Regulatory Intelligence and Policy, PDX

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Requirements:

• Bachelor's Degree in a Scientific or Engineering discipline
• A minimum of 7 years Regulatory Affairs / Quality Assurance experience in the pharmaceutical industry or regulator
• Experience developing regulatory strategies and leading regulatory agency interactions
• Experience with project management across global teams
• Excellent verbal and written communication and presentation skills

Responsibilities:

• Proactively monitor external regional and global sources for Regulatory Intelligence and Policy developments relevant to Pharma/Bio Pharma innovations and other innovative areas of importance to GE HealthCare.
• Assess the relevance and impact of regulatory intelligence information to GE HealthCare's products, processes, regulatory strategies, and market strategies.
• Communicate effectively with internal and external stakeholders on business critical aspects of regulatory intelligence.
• Collaborate with GE HealthCare regulatory teams across key markets to drive a proactive and consistent approach to monitoring of local environment and policy changes, and to ensure GE HealthCare has the opportunity to shape policy through proactive engagement and commenting opportunities.
• Work collaboratively with the Global Regulatory Intelligence & Policy team to maintain an effective strategy for external influencing engagement with trade associations, regulators, and other relevant stakeholders on the regional and global level to ensure GE HealthCare's voice and priorities are included in the development of future policy, regulations and guidance.
• Routinely engage and build relationships with a range of internal and external stakeholders, including cross-functional SMEs, trade associations, regulators, and other relevant industry stakeholders.
• Inform and influence others (internal and external) to find creative and strategically aligned solutions to address regulatory changes and/or complex issues that may impact GE HealthCare.