Regulatory Associate

5 days ago

Sydney, New South Wales, Australia Clinigen Full time

Clinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team. In this role, you will play a vital part in supporting the regulatory activities across Clinigen's portfolio, helping ensure that our products meet the highest standards of compliance and regulation.

Your primary responsibilities will include assisting in the preparation and submission of regulatory documents, maintaining up-to-date records, and providing support for regulatory inquiries. You will work closely with the Regulatory Affairs team and other departments to facilitate the timely delivery of projects and ensure that all regulatory submissions are accurate and complete.

This is an excellent opportunity for someone looking to grow their career in regulatory affairs and make a significant impact within a globally recognized organization.

  • Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field
  • 4+ years of experience in regulatory affairs or a related field within the pharmaceutical or healthcare industry
  • Demonstrated experience in a regulatory role servicing Australia and New Zealand.
  • Knowledge of TGA and Medsafe, other APAC regulatory knowledge is desirable.
  • eCTD publishing experience is desirable
  • Strong attention to detail and ability to manage multiple tasks effectively
  • Excellent written and verbal communication skills
  • Proficient in Microsoft Office Suite and ability to learn new software efficiently
  • Team player with a collaborative approach and strong interpersonal skills
  • Ability to work in a fast-paced environment and adapt to changing priorities

If you are passionate about regulatory affairs and eager to contribute to the success of our products, we encourage you to apply

In return, we can offer:

  • Competitive remuneration
  • Annual performance bonus
  • Flexible working arrangements
  • Ongoing support for professional development
  • Paid parental leave
  • Onsite parking

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