Regulatory Affairs Expert

3 weeks ago


Tennant Creek, Australia Innomar Strategies Full time

Our company, Innomar Strategies, is seeking a skilled Regulatory Affairs Expert to support our healthcare product submissions. Key responsibilities include coordinating and compiling regulatory submissions, responding to agency questions, and building relationships with internal and external contacts.

Responsibilities:

  • Compile and submit regulatory documents in accordance with agency requirements.
  • Collaborate with cross-functional teams to develop regulatory strategies.
  • Identify and address client and dossier issues.
  • Prioritize and monitor projects to meet budget, timelines, and client expectations.
  • Support client proposals and new business activities.
  • Travel as necessary to support clients and regulatory agencies.

Requirements:

  • Bachelor's degree in Life Sciences or equivalent experience.
  • Certification in Regulatory Affairs (RAC) and other relevant certifications.
  • 5+ years of experience in Regulatory Affairs or a related field.
  • Strong knowledge of local Health Authority regulations and guidelines.
  • Effective time management and problem-solving skills.


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