Regulatory Affairs Associate III

Watson Pharama

6 - 11 years

8 - 13 Lacs

mumbai navi mumbai

Posted:1 day ago| Platform:

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usage regulatory affairs associate sap anda pharma process improvement pharmacy life sciences regulatory affairs recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Associate III, with minimal to no guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines.
The Associate III will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and in the absence of any comments will progress the CC accordingly.
In addition, he/she will monitor any/all Regulatory or team databases and trackers and will proactively and accurately update them when changes are required. Annual Reports, supplements, post approval submissions and assisting management with the training of regulatory staff will be the primary responsibilities of Associate III.

How you ll spend your day

Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency
Independently work on supplements, compile and publish for managements review. Take a proactive approach to more complex submissions and contact internal stakeholders (when needed) to gain further insight into any given supplement. Convey findings to management and incorporate any. All applicable information in the submission to ensure quality and a right first-time submission.
Assist management and proactively train Associate I s and Associate II s on guidance s, internal processes, procedures, databases and trackers
Other projects and duties as required/assigned.
Process improvement

Your experience and qualifications

Bachelors in pharmacy/master s in pharmacy/Master in science & Life sciences
Min 6+ years of Regulatory affairs experience will be preferred in the respective (US) Markets.
Demonstrates an understanding of ICH and FDA guidelines
Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
Demonstrates excellent verbal and written communication skills.
Demonstrates excellent organizational skills and the ability to multi-task, detail oriented.
Possesses strong critical and logical thinking

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