Regulatory and Stability Associate
Regulatory and Stability Associate
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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
