Pioneering Medicinal Products Regulatory Expert

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $140,000
Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of our medicinal products and medical devices business, you will play a critical role in obtaining and maintaining marketing authorizations for our products in Australia and New Zealand.

  • Lead and manage activities such as compiling and submitting regulatory submissions according to requirements.
  • Manage regulatory activities relating to specific portfolios of products/projects with minimal supervision.
  • Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
Responsibilities:

Key responsibilities include providing regulatory advice to project teams, monitoring applicable regulatory requirements, ensuring compliance with company and external standards, preparing and following up submissions for new products and variations, analyzing the scientific content of selected new registration packages, keeping up-to-date with changes to regulations and standards, and advising management on the implications of such changes.

  • Support the regulatory activities relating to specific portfolios of products.
  • Liaison with local colleagues and Corporate Regulatory Affairs to ensure open and up-to-date communication of the status of products and projects and relevant regulatory requirements.
Requirements

To be successful in this role, you will have gained experience looking after a pharmaceutical drugs portfolio. You should have strong negotiation skills and experience in interacting with regulatory authorities, industry associations, internal and external stakeholders.

  • An experienced RA professional with the ability to think strategically and critically evaluate risks to regulatory activities.
Benefits

This is an excellent opportunity to work in a dynamic and innovative environment, making a positive impact on people's lives worldwide. You will have the chance to work on exciting projects, develop your skills and knowledge, and collaborate with a talented team of professionals.

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