Covance Regulatory Affairs Specialist Bachelor’s in Pharmacy
or related science degree
Job Overview:
- Prepare, compile & review Regulatory/Quality documents
to support submissions to various markets
- Coordinate and interact with other applicable client
departments to discuss and provide solutions to regulatory issues
- Seek guidance from other team members and manager as
needed, and enhance Regulatory knowledge
- Assist in preparation of Regulatory Affairs WI's for
Covance
- Perform additional duties as assigned by the manager
Education/Qualifications:
- Bachelor’s in Pharmacy or related science degree, or
equivalent qualification
Experience:
- 2+ years of pharmaceutical experience in Regulatory Affairs
/Quality Assurance
- Very good understanding of the pharmaceutical product life
cycle
- Very good knowledge of guidelines and regulations
pertaining to regulatory submissions for US, EU and other markets -Very good
Knowledge of cGMP and concepts of Quality Assurance
- Technical proficiency with Microsoft Office suite of
applications / Document Management and publishing tools
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