Compliance

• Provide leadership for all quality and regulatory aspects of Chemistry, Manufacturing and Controls (CMC)
• Assure optimal functioning of internal and external interfaces between CMC, Quality Assurance, Regulatory Affairs and stakeholders
• Proactively manage Regulatory aspects of CMC programs including understanding and ability to review internal and external source data for accuracy
• Responsible and accountable for secure vault data stream and quality of all data submitted
• Proactively manage Regulatory aspects with strong CMC focus
• Ensure timely delivery of high-quality CMC portion of documents
• Support and comply with procedures established by Quality and Regulatory Operations functions
• Facilitate the development of, reviews, and comments on all technically complex CMC documentation
• Articulate and resolve CMC issues to project teams and external stakeholders
• Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings
• Develop and maintain excellent relationships with regulatory authorities, corporate partners

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