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Teva Pharmaceuticals, a global leader in generics and specialty medicines, is inviting skilled professionals to join their Regulatory Affairs team in Navi Mumbai (Seawoods). If you have hands-on experience in US Post Approval regulatory activities, this is an excellent opportunity to grow your career with a world-renowned organization.
Position Details
Role: Regulatory Affairs Associate II – US Post Approval
Location: Seawoods, Navi Mumbai
Work Mode: Hybrid (3 Days/Week WFO)
Experience & Qualifications
Bachelor’s or Master’s in Pharmacy / Master’s in Science /Life Sciences
4-8 years of experience in the pharmaceutical industry
Mandatory: Experience in US Post Approval regulatory activities
◆ Key Responsibilities
Maintain approved ANDA applications in full compliance with FDA regulations, including preparation of Annual Reports
Proactively coordinate and request documentation required for annual report submissions
Independently compile, finalize, and publish annual reports for management review and submission to the Agency
Work independently on supplements; compile and publish for management review
Strong understanding of US FDA post approval requirements is essential
Interested candidates can share their updated CVs at:
apeksha.shinde01@teva.co.in
