Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Asst II PSS
Job Overview
• Prepare, compile & review Regulatory/Quality documents to support submissions to various markets
• Prepare deficiency responses, review labeling information, product monographs and marketing materials under supervision
• Prepare post approval supplements / annual reports to support changes and/or manage the regulatory product life cycle as applicable
• Seek guidance from other team members and manager as needed, and enhance Regulatory knowledge
• Perform additional duties as assigned by the manager
Candidate Profile
• Bachelor’s in Pharmacy or related science degree, or equivalent qualification
• + months of pharmaceutical experience in Regulatory Affairs /Quality Assurance Good understanding of the pharmaceutical product life cycle
• Good knowledge of guidelines and regulations pertaining to regulatory submissions for US, EU and other markets
• Good Knowledge of cGMP
• Technical proficiency with Microsoft Office suite of applications / Document Management and publishing tools Key
Additional Information
Experience : 6 + months
Qualification : B.Pharm, B.Sc
Location : Mumbai, India
Job ID : 45010
Industry Type : Pharma / Healthcare / Clinical research
End Date : 25th June, 2020
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