Director, Regulatory CMC Strategist

The Director,CMC Regulatory Affairs is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Celularity drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading CMC-specific HA meetings). The individual also performs regulatory assessments of proposed manufacturing changes and provides guidance on CMC regulatory expectations throughout development.

The individual functions as the Regulatory CMC lead on assigned project and submission teams by applying advanced knowledge of regulations and interpreting technical regulatory guidelines to ensure regulatory submissions are in compliance with applicable guidances and regulations.

This key role requires CMC regulatory expertise through all stages of a product's lifecycle, preferably in cellular therapies and involves development of regulatory CMC strategies. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.

• Responsible for the development of the CMC regulatory strategy for submissions including DMFs, IND, NDA/BLA and CTD regulatory filings
• Interact with regulatory agencies and represent Regulatory CMC at HA meetings, including preparing subject matter experts (SMEs).
• Responsible for assessment of all CMC related changes associated product, process and facilities/ equipment
• Responsible for submitting or ensuring submission of all regulatory documents that are required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories
• Coordinate, manage and lead all CMC regulatory projects including management of budget, timelines, and submission planning
• Align CMC regulatory strategy to overall regulatory business strategy (e.g. process, raw material, shelf-life and analytical changes)
• Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely world-wide applications
• Manage and ensure compliance with all CMC regulatory reporting requirements, including annual and periodic reports.
• Maintain knowledge of the US and global regulatory environment, regulations, and procedures. Identify regulatory opportunity and risks across development lifecycle.
• Review and provide regulatory assessments for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable implementation.
• Prepare and manage CMC submissions while ensuring thoroughness, completeness, and timeliness working in collaboration with SMEs in Research, Process Development, Manufacturing, Quality, and Supply Chain. Maintain responsibility for all CMC Regulatory timelines in collaboration with Program Management.

• • BS/BA degree (or equivalent) in a relevant scientific field required; advanced degree (MS or PhD) is preferred.
  • A minimum of 8+ years of experience in regulatory affairs with a focus on CMC documentation and CMC lifecycle management within the pharmaceutical or biotechnology industry is a must.
  • Proficient in CMC regulatory requirements across development stages and post-approval is essential. Experience with CMC regulations for:
    • Biologics is required
    • Cell/gene therapy is desired. Viral Manufacturing is preferred.
    • Combination products is desired
    • Knowledge of FDA and ICH CMC guidance documents and regulations information required.
  • Demonstrated ability to: develop/maintain strong working relationships with the CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle, and prioritize multiple projects and work independently.
  • Flexible with demonstrated ability to work in a fast-paced, timeline-driven environment.
  • Excellent problem-solving and decision-making skills; provides strong critical thinking and constructive feedback.
  • A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical need.
  • The role will be hired at the level commensurate with experience.