Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Post : Regulatory Affairs Associate II
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
Candidate Profile
• M. Pharma degree in RA/QA discipline, a plus.
• Minimum 4+ years 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
Additional Information
Experience : Minimum 4+ years
Qualification : M.Pharma degree
Location : Navi Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th November 2026
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