Regulatory CMC Lead


Junto HLS is working exclusively with a top consumer healthcare company in Northern New Jersey which has tasked us with recruiting a Regulatory CMC Lead to work across their top OTC brands, a line of Vitamins, Minerals, and Supplements, and a line a of Hygiene products, many of which you’d be familiar with as both a professional and a consumer.

Responsibilities Overview:

  • Manage Chemistry, Manufacturing, and Control US Regulatory department responsibilities as well as CMC project assignments including managing or assisting in the coordination, review, compilation, assembly, filing and tracking of CMC sections of NDAs, INDs, Annual Reports and device 510k submissions.
  • Responsible for providing CMC input for OTC drug monograph products and for medical devices and will support the regulatory activities in the global expansion of US products and US registration and launch of global products.
  • Write departmental SOPs/Work Practices to ensure that department work performance is consistent, efficient and without compliance lapses
  • Reviewing, determining filing requirements and approving CMC changes to support commercial operations and new product development in compliance with US and international change control systems
  • Compiling and reviewing CMC sections of NDA annual reports
  • Prepare supplements, amendments and correspondence for NDA CMC changes
  • Providing CMC regulatory support for global brand expansion including reviewing Quality modules for CTD and preparing applications for FDA Certificates of Pharmaceutical Products (CPPs)
  • Providing CMC regulatory input into development and innovation projects
  • Providing regulatory support to Supply for export/import issues
  • Preparing/reviewing device 510k submissions
  • Monitoring FDA and other regulatory initiatives to assure company compliance with current and emerging regulatory requirements
  • Coordinating/liaising with internal and external resources to assure regulatory compliance
  • Provide regulatory assessments for changes to drug and device products including process, material, packaging and other changes to meet Supply, Marketing and Regulatory initiatives, timelines and requirements
  • Monitor regulatory requirements and prioritize tasks to support project launch dates and meet timelines
  • Update, maintain and develop departmental and company electronic tracking systems and databases


  • Northern NJ

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