Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job ID: 66324
Experience Required: 2+ years in Regulatory Affairs or relevant pharmaceutical/biotech experience
Job Category: Regulatory Affairs / Pharmaceutical Compliance
Job Type: Full-Time, Permanent
Teva Pharmaceuticals is a global leader in generic medicines and biopharmaceuticals, committed to making healthcare more affordable and accessible. Our medicines reach over 200 million people worldwide every day, including products on the World Health Organization’s Essential Medicines List. Teva fosters an inclusive, collaborative culture that values professional development, innovation, and global impact.
The Regulatory Affairs Associate I provides regulatory support under direct supervision, primarily preparing annual reports, supplements, and amendments for U.S. FDA submissions. This role involves assisting in evaluating change controls, maintaining regulatory documentation, and accurately updating team databases and trackers. The Associate will gain experience in regulatory submissions and contribute to ensuring FDA compliance for assigned ANDAs.
Prepare annual reports and, with experience, assist in preparing supplements for FDA submissions.
Review supporting documentation for change controls, including batch records, methods, and specifications, ensuring completeness and regulatory compliance.
Learn and apply applicable FDA regulations and guidance in support of filing determinations and change control processes.
Maintain approved applications in compliance with FDA regulations for assigned ANDAs.
Accurately populate and maintain regulatory databases and trackers in real-time.
Assist in additional projects and departmental duties as assigned.
M. Pharma degree; specialization in Regulatory Affairs or QA is preferred.
Minimum 2 years of experience in Regulatory Affairs or relevant experience in analytical/QC, R&D, laboratory, or production in the pharmaceutical/biotech industry.
Basic computer skills including Word, Excel, and internet navigation.
Strong organizational skills, attention to detail, and ability to manage multiple priorities.
Good verbal and written communication skills, with ability to work independently and collaboratively.
Reports to Regulatory Affairs Manager or designated supervisor.
Competitive benefits including flexible working schedules and access to health and wellness support.
Career development opportunities through Twist, Teva’s internal platform for learning, projects, and growth.
Collaborative, inclusive culture that encourages professional development and global impact.
Teva Pharmaceuticals is committed to equal employment opportunity. All employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, or any legally protected status. Teva promotes diversity, inclusion, and accessibility in recruitment and ensures confidential accommodations throughout the selection process.
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