Principal Scientist, Regulatory CMC

Position Summary

The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format.

Essential Functions

• Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards
• Contribute to the development of global CMC regulatory strategies
• Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation
• Provide expert opinion on CMC topics planned or performed
• Contribute to the design of CMC protocols
• Interact with other groups when needed to address CMC related matters
• Affiliate with the preparation of responses to Health Authority comments and questions pertaining to CMC issues
• Train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate

Education & Experience

• Bachelor’s Degree in life sciences or technical discipline with 10+ years relevant progressive experience required
• or Master’s Degree in life sciences or technical discipline with 8+ years relevant progressive experience required
• or Doctorate degree in life sciences or technical discipline with 6+ years relevant progressive experience required
• Experience in the preparation of the submission of CMC modules in eCTD format required
• Familiarity with organizing responses to Health Authority requests required
• Familiarity with regulatory submissions outside of the US desired

Knowledge, Skills, & Abilities

• Knowledge of Health Authority procedures and guidance regarding document management and electronic submission
• Knowledge of Health Authority CMC guidance documents and requirements
• Proficient in Electronic Document Management Systems
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written and oral communication skills, and attention to detail
• Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred