Senior Regulatory Writing

Role and Responsibilities:

 Your roles & responsibilities include, but are not limited to:


  • Scientific documents like manuscripts, abstracts, posters, slide decks, training content, white papers, internal and external reports
  • Regulatory documents like dossiers for product approval: CER, 510 (k) filing, IVD submissions, responding to regulatory queries
  • Medico-marketing documents like newsletters, product monographs, brochures, leave behind leaflets, patient education
  • Development of technical SOP’s and technical processes to ensure quality of documents and deliverables

Training & Development

  • Prepare training plan for internal and external trainings
  • Development of content for internal and external workshops and client projects.
  • Take trainings sessions, review the assignments and give feedback to the students
  • Subject matter expert for medical device and IVD training content


Project and Client Management

  •  Track the progress of projects and individual document assigned to the team. Estimate effort hours and track work in progress.
  • Supporting BD with their queries for prospective projects.
  • Manage client communication for all the assigned projects.
  • Prompt response to client emails and resolving client queries/concerns
  • Resource allocation and team alignment