Compliance

• Conducting global regulatory change assessments and coordinating associated activities for assigned products.
• Supporting global regulatory strategies for changes related to spin-off continuity projects and ensuring these strategies are integrated with the overall RA spin-off plans.
• Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality
• Demonstrating excellent organizational, prioritization, oral and written communication skills
• Providing regulatory review of technical reports and documents.
• Providing contributions for development and implementation of regulatory processes.
• Documenting and managing metrics.
• Leading regulatory filings as needed for continuity projects (directly for EU/USA, Canada and supporting ROW).
• Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.
• Communicating results of technical tasks to teams, respective business group(s) and/or country/region served via reports, standards and/or presentations.
• Leading the implementation of key corporate initiatives and appropriate tools.

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