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Regulatory Affairs Associate III

Regulatory Affairs Associate III

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Watson Pharama

7 - 9 years

9 - 11 Lacs

mumbai navi mumbai

Posted:1 day ago| Platform:

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Job Description

Regulatory Affairs Associate III Job Details | Teva Pharmaceuticals

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Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate III Navi Mumbai, India, 400706

Who we are

The opportunity

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
7-9 year s experience in the Pharmaceutical Industry: Regulatory, Analytical, QA, laboratory or production experience preferred.
Min 6+ years of RA experience will be preferred in the respective 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.

Teva s Equal Employment Opportunity Commitment

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Regulatory Affairs Associate III