Senior Manager Regulatory CMC
With a focus on the treatment of rare diseases, my client is one of the most innovative biopharma companies world-wide. They currently have five marketed products with over half a billion dollars in revenue and a strong pipeline. They are seeking a Senior Manager of Regulatory CMC to work on both post-approval and development programs globally. This is an incredible time to join this company as they will be filing four MAA and NDA’s over the next three years. Come join an entrepreneurial environment where you can tangibly impact patient’s lives and also the future of the company!
Responsibilities:
- Manage global regulatory CMC activities for an approved small molecule drug program and also support a gene therapy program in development.
- Ensure that CMC content is complete, well-written, and meets all relevant requirements
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide strategic regulatory guidance for optimal implementation of changes
- Research and interpret global CMC regulations and, provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups
- Manage two associates
- Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
- Manage interactions with FDA and other global regulatory authorities for assigned project to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments, supplements/variations, and other submissions which present CMC information
- Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners
Knowledge and Skills:
- Minimums BS required, advanced degree preferred
- 4-6 years of experience in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in Small Molecule Drugs, Biologics, and/or Gene Therapy and deep experience in Phase 1-3
- Thorough understanding of relevant drug development regulations and guidelines is essential
- Prior success filing CMC sections for clinical trial applications, marketing applications, amendments, supplements, and variations for solid oral dosage form products within timelines is required
- Global submission experience desired
- Demonstrated ability to coach, train and mentor teams
- Outstanding interpersonal and communication (written and verbal) skills is required
- Strong writing and editing skills for technical documentation