Key Responsibilities
- Provide leadership and guide the overall CMC regulatory strategy for all programs from early development through to marketing applications and post marketing activities
- Influence strategy to address internal or external business and regulatory issues and proactively identify potential strategic issues and opportunities
- Develop submission plans and timelines for CMC in partnership with all other Regulatory subject matter experts for coordination
- Drive and execute the CMC regulatory activities that lead to successful IND/CTA and global marketing applications
- Identify, assess, and communicate potential risks associated with development and regulatory strategy scenarios and plan risk mitigation strategies
- Interact directly with global regulatory agencies and ensure that interactions are properly communicated to the CMC teams and/or business partners. Triage, coordinate and manage responses to questions from regulatory authorities by collaborating with the CMC teams to address regulatory agency feedback and define long and short-ranged actions
- Responsible for the coordination, timely preparation, review and submission of CMC documentation packages for regulatory agency interactions
- Direct or manage resources of the authoring and preparation of CMC sections as applicable
- Review product development and technical documentation for regulatory compliance and inclusion in submissions global regulatory agencies
- Work collaboratively on cross functional teams, including process development, manufacturing, supply chain, quality, and regulatory to manage activities and/or changes related to product development, manufacturing, and commercialization
- Manage external regulatory consultants and project deadlines
- Ensure compliance with company standards and the applicable regulations
- Review product labeling for clinical trial and commercial labeling
Minimum Requirements/ Qualifications
- BA/BS degree required, MS preferred, in an appropriate scientific field with 15+ plus years direct professional experience in CMC development in biopharmaceuticals; strong understanding of cell and gene therapy drug development and regulatory approval process
- Detail-oriented, organized, with ability to influence others and a customer-focused mindset
- Strong understanding of biotech/cell & gene therapy regulations essential (ICH and other governing documents, US and Global), rare disease experience preferred
- Comfortable in agile environments; capable of bringing structure to vaguely defined problems while using creative yet pragmatic problem-solving approaches
- Highly effective written and verbal communication skills; strong presentation, facilitation, and stakeholder management skills
- Demonstrated experience in CMC development and implementation of business processes that enhance organizational sustainability
- Demonstrated ability to coach team leaders in navigating the complexities of a cross-functional, matrixed organization that is dynamic and rapidly evolving
- Inclusive interpersonal skills; ability to build relationships, influence, and drive organizational change
