drjobs Regulatory and Stability Associate

Regulatory and Stability Associate

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1 Vacancy
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Job Location drjobs

Melbourne - Australia

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

About this opportunity

 Reporting to the Product Development Manager The Regulatory and Stability Associate is responsible for ensuring product compliance with the relevant regulatory bodies. The associate coordinates stability studies to assess label claims and active efficacy.

  Liaise with sponsor and coordinate with external testing facility to conduct stability tests and studies Reviewing stability data to establish shelflife and trend evaluations Review and assess regulatory market compliance for medicines Prepare medicine submissions to the relevant regulatory bodies Ensure product safety and active efficacy is reviewed and safe for use Review product claims and label requirements and ensure compliance is met Aid investigations of Out of Specification/Out of Trend (OOS/OOT) results and assist in determining root cause

Your key responsibilities will be to:

 Liaise with sponsor and coordinate with external testing facility to conduct stability tests and studies

Review stability data to establish shelflife and trend evaluations

Review and assess regulatory market compliance for medicines

Prepare medicine submissions to the relevant regulatory bodies

Ensure product safety and active efficacy is reviewed and safe for use

Review product claims and label requirements and ensure compliance is met

Aid investigations of Out of Specification/Out of Trend (OOS/OOT) results and assist in determining root cause

Your skills and experience

To be successful in this role youll have:

  • A keen eye for detail
  • Advanced SAP and Excel experience
  • Strong interpersonal communication & presentation skills
  • Qualifications in Chemical engineering

Remote Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

Company Industry

About Company

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