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Work as Junior Regulatory Affairs Specialist @ Covance

Work as Junior Regulatory Affairs Specialist @ Covance

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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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