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0.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Work Schedule Standard (Mon-Fri) Environmental Conditions Office About The Role We seek a highly skilled Country Approval Specialist to join our Clinical Operations team in India. This outstanding opportunity lets you lead/exel in clinical operations team and collaboration. As a vital team member, you will ensure flawless execution of study startup phase, meeting all regulatory requirements and industry standards. Responsibilities Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions. Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast timelines for the cr...

Posted 1 day ago

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0.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Job Description : Work Schedule Standard (Mon-Fri) Environmental Conditions Office About the Role We seek a highly skilled Country Approval Specialist to join our Clinical Operations team in India. This outstanding opportunity lets you lead/exel in clinical operations team and collaboration. As a vital team member, you will ensure flawless execution of study startup phase, meeting all regulatory requirements and industry standards. Responsibilities Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions. Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast ti...

Posted 6 days ago

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7.0 - 9.0 years

0 Lacs

mumbai, maharashtra, india

On-site

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com. Job Summary Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets. Maintenance of documentation/database records pertaining to approved products in l...

Posted 2 weeks ago

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