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Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

The Regulatory Affairs Specialist will create and review regulatory documentation for drug, device, and combination product renewals. This role involves interacting with non-regulatory support groups to request necessary documentation, tracking the status and progress of regulatory documents, and coordinating responses to regulatory authority renewal questions under supervision.

Responsibilities

  • Create and review regulatory documentation for drug, device, and combination product renewals.
  • Interact with non-regulatory support groups (e.g., manufacturing, product stability, quality, clinical) to request documentation necessary to support product renewals.
  • Track the status and progress of regulatory documentation used for renewals.
  • Coordinate and compile responses to regulatory authority renewal questions under supervision.
  • Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities.
  • Answer internal queries for assigned products.
  • Maintain a database of regulatory requirements for renewals.

Qualifications

  • Knowledge of regulations and scientific principles.
  • Strong administrative and project management skills.
  • Ability to contribute to multiple projects from a regulatory affairs perspective.
  • Ability to multitask and prioritize effectively.
  • Excellent interpersonal and communication skills.
  • Proficient in technical systems (e.g., word processing, spreadsheets, databases, online research).
  • Strong proofreading and editing skills.
  • Ability to independently identify compliance risks and resolve or escalate them as necessary.

Skills

  • Experience in creating and reviewing regulatory documentation.
  • Ability to interact effectively with cross-functional teams.
  • Proficiency in tracking and managing regulatory document status and progress.
  • Competence in coordinating responses to regulatory authority questions.
  • Familiarity with electronic document management systems.
  • Strong organizational skills to maintain regulatory requirement databases.
  • Ability to manage multiple priorities and projects simultaneously.
  • Excellent written and verbal communication skills.

Application Link