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.

Location(s):

    • Northern, NJ

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.