Regional Regulatory Compliance Specialist

14 hours ago

Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $29,280 - $60,912
Job Overview

We are seeking a highly skilled professional to fill the role of Regulatory Region Manager. This position involves contributing to the compilation of relevant high-quality documentation for submissions in the region. This includes applications for new licenses, variations, license renewals, responses to questions, clinical trials, orphan drug designations, PSURs, DSURs, and changes according to agreed schedules.

The successful candidate will be responsible for coordinating with stakeholders, managing deadlines, and ensuring timely submission of high-quality documents.

Key Responsibilities
  • Coordinate the compilation of high-quality documentation for regulatory submissions
  • Manage deadlines and ensure timely submission of documents
  • Collaborate with stakeholders, including cross-functional teams and external partners
  • Develop and maintain knowledge of regulatory requirements and guidelines
  • Provide support and guidance to colleagues on regulatory matters
Requirements
  • Bachelor's degree in a relevant field (life sciences, regulatory affairs)
  • Excellent communication and analytical skills
  • Attention to detail and ability to work accurately under pressure
  • Strong problem-solving skills and ability to think critically
  • Ability to work independently and collaboratively as part of a team
  • Experience in regulatory affairs and/or life sciences industry

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