Regulatory Affairs Associate II

2 - 6 years

6 - 7 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • 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 supplement 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
  • M. Pharma degree in RA/QA discipline, a plus.
  • Minimum four years plus pharmaceutical industry experience; 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 on teams
  • Good verbal and written communication skills
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

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