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 : Junior Regulatory Affairs Specialist
Job Description
- 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
- 6 + months of pharmaceutical experience in Regulatory Affairs /Quality Assurance
- Fresh graduates and 6 + 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
Additional Information
Experience : Fresh graduates and 6 + months
Qualification : B.Pharm
Location : Mumbai, India
Industry Type : Pharma / Healthcare/ Clinical research
Job ID : 47625
End Date : 25th July, 2020
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