Regulatory CMC Team Leader

Junto HLS is working exclusively with Regulatory Leadership at a top healthcare company in Northern New Jersey to recruit a Regulatory CMC Team Leader to oversee North American Regulatory Affairs CMC. The incumbent will lead RA CMC work across a multitude of market leading products/projects, many of which you’d be familiar with as both a professional and a consumer.

Position Overview:

  • Manage CMC Regulatory team and ensure all project milestones are met and CMC support for marketed products is provided in accordance with established deadlines;
  • Deliver all CMC Regulatory milestones for assigned products across the product lifecycle;
  • Identify, communicate and escalate potential CMC Regulatory issues to Regulatory Management and communicate mitigation strategies;
  • Provide CMC Regulatory leadership as needed to product in-license/due diligence review, product divestment;
  • Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle;
  • Execute CMC Regulatory strategies by review of CMC submission components and documentation to support post-approval supplements, annual reports, and registration and responses to FDA questions per established business processes and systems;
  • Collaborate with R&D and other cross-functional partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance;
  • Represent company in technical Trade Associations;
  • Gather and analyze technical Regulatory information and lead the implementation into company procedures;
  • Assist CMC Regulatory team members with career development and yearly business and development objectives.  Conduct meaningful reviews with team members to ensure alignment with departmental objectives and personal development goals.


    • Northern, NJ

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