Senior Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $160,000
Job Summary

We are seeking a highly skilled Regulatory Affairs Professional to join our team in the Asia-Pacific region. This role will be responsible for working with local regulatory affairs departments, cross-functional teams, and global functions to define and implement regional strategies for assigned products.

The ideal candidate will have a strong understanding of regional and local requirements and be able to advise on applicable regulatory requirements, guidelines, and processes. They will also be able to participate as a standing member of project-related Global Regulatory Teams, support the development of strategies to accelerate submissions and approvals, and provide input in post-registration activities.

  • Key Responsibilities:
  • Provide regional regulatory expertise and strategic input into global regulatory strategies
  • Identify regional requirements to optimize registration and lifecycle management of marketed products
  • Participate in Health Authority interactions and facilitate discussions on regional or global regulatory issues
  • Coordinate and review regulatory submissions, including lifecycle submissions and labeling changes
  • Deliver business-critical regulatory submissions in line with development and post-marketing priorities and timelines

This is an exciting opportunity to work in a dynamic environment and contribute to the success of our organization. If you have a passion for regulatory affairs and a strong track record of delivering results, we encourage you to apply.

Requirements
  • Bachelor's degree in pharmacy or life-science or health-related discipline
  • 6-10 years of experience in the pharmaceutical industry, preferably in regulatory affairs
  • Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements
  • Demonstrated ability to handle multiple projects and strong organizational skills
  • Ability to communicate to senior level management and working knowledge of regulations in the region
What We Offer
  • Opportunity to work in a dynamic environment
  • Chance to contribute to the success of our organization
  • Professional development and growth opportunities
  • Competitive compensation and benefits package

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