Pharmaceutical Regulatory Compliance Expert
8 hours ago
This is a highly skilled role that requires expertise in regulatory compliance and change management within the Pharmaceutical/Biotechnology industry.
Key Responsibilities:
- Review change records to evaluate impact on reportability and product restrictions for any product in scope.
- Determine and document reporting and product distribution restriction requirements for changes within the change control management system.
- Collaborate with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies.
Required Skills and Qualifications:
- Masters degree or equivalent qualification in Life Science discipline.
- Bachelor's degree and 2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
- Associate's degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
- Diploma and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
Benefits:
- Opportunity to work in a dynamic and innovative industry.
- Chance to develop expertise in regulatory compliance and change management.
- Potential for career advancement in a growing company.
Others:
If you are passionate about working in the Pharmaceutical/Biotechnology industry and have relevant qualifications, please apply for this exciting opportunity.
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