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Regulatory Affairs Associate III

Teva PharmaceuticalsNavi Mumbai, Maharashtra, India

30+ days ago

Job description

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

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

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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Associate Regulatory • Navi Mumbai, Maharashtra, India