Regulatory Team Leader

Junto HLS has been engaged by Regulatory Leadership at a top healthcare company in Northern New Jersey to recruit a Regulatory Team Leader to lead a team of 6 RA professionals across a product portfolio that includes a $500MM OTC brand.

Position Overview:

  • BS degree required; advanced degree in a scientific discipline desired.
  • Manage day-to-day operations of the OTC team; including managing overall workload, development of team members, and ensuring all product and project-related milestones are met.
  • Develop and implement Regulatory strategies to ensure successful launch, promotion, and compliance, for both marketed Healthcare products and products in development. Lead/co-lead meetings with FDA during product negotiations.
  • Maintain close working relationship with the Global Regulatory Team to ensure alignment of local (US) Regulatory strategies with Global/Regional strategies.
  • Provides Regulatory support and expertise to project teams, through Regulatory strategies and consultation on deliverables that could potentially impact the project/product.
  • Ensure compliance with all internal and external regulatory requirements.
  • Responsible for the analysis and evaluation of regulations and provides expertise in translating regulatory requirements into practical, workable plans in the US.
  • Oversees the evaluation and analysis of the impact of trends relative to government regulatory agencies.
  • Oversees, manages and implements the preparation of major regulatory filings, and ensures timely completion of routine regulatory submissions required for maintenance of in-market products. Reviews technical reports prepared in support of regulatory filings.

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.