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Regulatory Affairs Associate II

Regulatory Affairs Associate II

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

4 - 5 years

6 - 7 Lacs

mumbai navi mumbai

Posted:1 day ago| Platform:

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Job Description

Regulatory Affairs Associate II 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 II Navi Mumbai, India, 400706

Who we are

The opportunity

The Associate II, with moderate to minimal guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines.
The Associate II will be responsible for independently evaluating change controls (intended for post approval changes), will ensure the CC is complete and accurate and will consult his/her manager/designee prior to progressing the CC.
In addition, he/she will accurately populate and maintain any/all Regulatory or team databases and trackers in real time, as directed by their manager or Designee. Annual reports, supplements and post approval submissions will be the primary responsibilities of Associate II.

How you ll spend your day

Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review.
Under management s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplements to gain experience.
Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidance s to understand and accurately assess change controls.
When needed, train Associate I s on internal processes, procedures, databases and trackers.
Other projects and duties as required/assigned

Your experience and qualifications

Bachelors in Pharmacy/Master in science & Life sciences- 4-5 Years in the Pharmaceutical Industry: Regulatory, Analytical, QA, laboratory or production experience preferred.
Master in Pharmacy-3-4 Years in the Pharmaceutical Industry: Regulatory, Analytical, QA, laboratory or production experience preferred.
Basic computer skills such as Word, Excel and familiarity with the internet
Ability to work independently and in teams
Good verbal and written communication skills
Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

Teva s Equal Employment Opportunity Commitment

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Regulatory Affairs Associate II