Country Regulatory Affairs Specialist

24 hours ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Country Regulatory Affairs Specialist

A key role in our organization is the Country Regulatory Affairs Specialist, who plays a critical part in ensuring that clinical trials are managed efficiently and effectively.

The primary responsibilities of this position involve preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.

This involves working closely with investigators and local regulatory authorities to ensure submissions are managed in a timely manner. The successful candidate will have excellent communication and organizational skills, with the ability to work independently and as part of a team.

The ideal candidate will possess a strong understanding of regulatory requirements and experience in a similar role would be highly advantageous.

In addition to the above-mentioned responsibilities, the Country Regulatory Affairs Specialist will also be involved in developing and implementing local submission strategy, providing technical expertise and coordination oversight for projects in collaboration with relevant internal departments.

The role requires excellent problem-solving skills, attention to detail and the ability to prioritize tasks effectively.

Key Responsibilities:

  • Serving as primary contact for investigators and local regulatory authorities.
  • Ensuring guidelines and processes are followed for effective internal communications and communications with investigators and country regulatory authorities.
  • Participating in Submission Team Meetings, Review Meetings and Project Team meetings.
  • Coordinating with internal functional departments to ensure site start-up activities are aligned with submissions activities and mutually agreed upon timelines.

About the Role:

This is an exciting opportunity to work in a dynamic environment where you will have the chance to make a meaningful contribution to the success of clinical trials.

As a Country Regulatory Affairs Specialist, you will play a critical role in ensuring that submissions are managed effectively and efficiently.

You will have the opportunity to work closely with investigators and local regulatory authorities to ensure that clinical trials are conducted in accordance with regulatory requirements.

Requirements:

  • Strong understanding of regulatory requirements.
  • Experience in a similar role would be highly advantageous.
  • Excellent communication and organizational skills.
  • Ability to work independently and as part of a team.

Benefits:

This role offers a competitive salary and benefits package, including opportunities for professional development and growth.

We are committed to creating a diverse and inclusive workplace culture that values and respects all employees.

How to Apply:

If you are a motivated and experienced individual looking for a new challenge, please submit your application, including your resume and cover letter.

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