Lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities
Work with cross-functional teams across development, manufacturing, quality and regulatory to prepare submissions and respond to regulatory requests
Drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents
Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies
Mentor or train staff and may have direct line management responsibility
Manage project activities for multiple complex projects and teams simultaneously
Provide strategic direction, data assessment and conclusions within and across departments
Engage and may lead CMC Subject Matter Expert activities, internally and externally
Deliver CMC regulatory strategy to support major inspections or quality incidents
Ensure all appropriate CMC regulatory aspects for product release are in place
Formulate novel approaches and influence people, evaluating/improving CMC Regulatory processes and systems

Bachelor’s degree in life sciences, pharmacy, chemistry, engineering or related field
6+ years of CMC regulatory experience in pharmaceutical, biologic, device or combination product development
Experience preparing and contributing to regulatory submissions (CTD modules, amendments, INDs, BLAs/NDAs or equivalents)
Experience GMP and manufacturing processes and how they relate to regulatory submissions
Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
Experience handling complex global CMC issues through continuous change and improvement
Experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management)

Senior CMC Regulatory Strategy Manager

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