Regulatory Operations Lead

 

Junto HLS is working directly with Regulatory Leadership, at a top consumer healthcare company in Northern New Jersey, to recruit a qualified Regulatory Operations Lead to work across a number of products/projects, many of which you’d be familiar with as both a professional and a consumer.

Select Accountabilities:

  • Provide regulatory requirements for development of local product development strategy
  • Implement and execute product regulatory strategy, delivering against project milestones
  • Approve finished product labels to ensure regulatory compliance.
  • Assemble, file and maintain any product registration, on a Federal, State, or local basis
  • Design and maintain regulatory related files
  • Create, update, and maintain regulatory processes and related SOPs
  • Coach/maintain department’s directives, processes, procedures and metrics
  • Coordinate regional regulatory activities necessary to ensure and obtain compliance with regional and global regulations
  • Monitor, collect and interpret regional regulatory issues and trends that will impact company products, policies and procedures
  • Negotiate and resolve issues raised by regulatory authorities
  • Attend industry association meetings and/or other organizations in North America and report information on new, proposed or modified regulations to management
  • Develop and maintain a database of registration activities, project status, and regulatory metrics
  • Manage external resources to expedite document reviews and submissions to meet timelines

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 Michelle@juntoHLS.com.