Site Activation Regulatory Strategist

2 days ago

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

A key role in ensuring timely and accurate submissions to regulatory authorities. This specialist will work closely with internal departments to align site start-up activities with submission processes.

Main Responsibilities:
  • Prepare, review and coordinate local regulatory submissions in line with global submission strategy.
  • Provide local regulatory strategy advice to internal clients.
  • Develop and implement local submission strategy, providing technical expertise and coordination oversight for projects.
  • Serve as primary contact for investigators and local regulatory authorities to ensure submissions are managed in a timely manner.
  • Ensure guidelines and processes are followed for effective internal communications and with country regulatory authorities.

The successful candidate will have strong communication and project management skills, with the ability to work effectively in a team environment. They will be responsible for achieving target cycle times for site activations and preparing compliance review packages.

About Our Partnership:

We provide our teams with the resources needed to achieve individual career goals while taking science forward through research, development and delivery of life-changing therapies.

We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

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