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Executive - Regulatory Affairs (API) Animal Health

Executive - Regulatory Affairs (API) Animal Health

People Genix

3 - 8 years

5 - 7 Lacs

Bengaluru

Posted:3 hours ago| Platform:

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Skills Required

Regulatory Affairs Dossier Preparation Anda Dossier Compilation Dmf Drug Regulatory Affairs EU CTD Japan Europe Dossier NDA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates working in formulations may skip this job post.

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People Genix

peoplegenix.com

Human Resources Services

Gurugram Haryana

2-10 Employees

22 Jobs

Key People

Alice Johnson

CEO
Bob Smith

CTO
Carol Tan

Head of Marketing

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Executive - Regulatory Affairs (API) Animal Health