CMC Regulatory Affairs Consultant
Remote
12+ Months

Candidates should be located in USA. W2 candidates only

Duties and Responsibilities:

• Proactively manage CMC aspects including overseeing preparation and submission of CMC submissions – including clinical trial applications.
• Develop and assess CMC content to ensure it is complete, well-written, and meets all pertinent requirements.
• Stay up-to-date on current and evolving regulatory CMC requirements – apply this knowledge to assigned projects, and provide regulatory direction to the Quality, Manufacturing, Process Development and other functional groups and stakeholders.
• Head projects with cross-functional teams and acts as the main regulatory CMC contact for assigned projects.
• Participate in the design, development and execution of regulatory strategies, regulatory risk management and contingency plans.
• Perform regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development.
• Assist with FDA and other global regulatory authority interactions for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications as well as other submissions with relevant CMC information.

Required:

• Bachelor’s Degree or higher required (life sciences disciplines strongly preferred).
• 10+ years’ experience in life sciences
• 5+ years’ relevant experience in regulatory affairs or related functions in drug or biologics development.
• Experience as a regulatory contributor for global original IND, NDA, BLA MAA, filings in the US or Europe.
• Cell and Gene therapy experience preferred.