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Regulatory Affairs Associate I

Regulatory Affairs Associate I

Watson Pharama

1 - 3 years

6 - 7 Lacs

mumbai navi mumbai

Posted:Just now| Platform:

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Skills Required

selection process adobe acrobat usage regulatory affairs associate sap publishing pharma life sciences manager quality control recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
Collaborate with scientific personnel for planning, preparation and publishing
Maintain working knowledge of internal and external publishing standards.
Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

Your experience and qualifications

B. Pharm/M. Pharm/ Master of Life Sciences.
Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
Command over spoken and written English
Sensitivity to the cultural diversity of a global organization
Good understanding of regulatory IT systems

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Regulatory Affairs Associate I