Country Regulatory Specialist

3 days ago

Sydney, New South Wales, Australia beBeeCountry Full time $83,100 - $124,950
Job Title: Country Regulatory Expert

Our company is seeking a highly skilled and experienced Country Regulatory Expert to join our team.

As a key member of our global regulatory team, you will be responsible for managing the preparation, review, and coordination of Country Submissions in line with our global submission strategy.

  • Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with our global submission strategy.
  • Provides local regulatory strategy advice to internal clients.
  • Develops and implements local submission strategies, providing technical expertise and coordination oversight for projects in collaboration with relevant internal departments.

You will serve as the primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner.

The ideal candidate will have previous relevant study start-up experience, therapeutic experience in Oncology, and Phase I experience. They will possess excellent oral and written communication skills, strong attention to detail, and good negotiation skills.

Key Requirements:

  • Minimum 5 years of experience in country regulatory roles.
  • Proven track record of successful regulatory submissions.
  • Excellent communication and interpersonal skills.

What We Offer:

  • Competitive salary and benefits package.
  • Ongoing training and development opportunities.
  • Collaborative and dynamic work environment.

How to Apply:

If you are a motivated and experienced Country Regulatory Expert looking for a new challenge, please submit your application.

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