Location: Navi Mumbai, Maharashtra, India
Position: Regulatory Affairs Associate I
Job ID: 62820
Company: Teva Pharmaceuticals
🌐 About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in the manufacturing of generic medicines and is recognized as a major contributor to public health. With operations in nearly 60 countries and products impacting over 200 million people daily, Teva is committed to making quality healthcare accessible and affordable around the world.
Now, Teva is looking for a skilled and passionate Regulatory Affairs Associate I to join its team in Navi Mumbai.
📝 Key Responsibilities
- Prepare, revise, and finalize US Gx labeling documents for ANDA and/or 505(b)(2) submissions.
- Create and manage Structured Product Labeling (SPL) files, ensuring compliance with drug listing regulations.
- Support electronic submission preparation for FDA, including side-by-side comparisons and SPL development.
- Conduct quality checks (QC), proofreading, editing, and formatting of documents.
- Collaborate with Regulatory Operations and use eCTD publishing software for timely project submission.
- Ensure strict compliance with US FDA regulations and guidelines.
- Work efficiently in a team environment and support process improvements.
🎓 Qualifications & Skills
- Education:
- B.Pharm / M.Sc / Life Sciences: 2–3 years of relevant experience
- M.Pharm: 1–3 years of experience
- Required Skills:
- Proven experience in regulatory affairs (focus on US Gx labeling)
- Knowledge of SPL development, eCTD submission standards, and drug listing
- Strong understanding of FDA regulations and guidelines
- Proficient in Microsoft Word, Excel, and Adobe Acrobat Professional
- Familiarity with TVT (electronic proofreading tool) is preferred
- Excellent communication skills, attention to detail, and ability to multitask
🌟 Why Join Teva?
- Be part of a mission-driven organization that’s making a global impact
- Work with a team of professionals committed to regulatory excellence
- Career growth in one of the world’s most respected pharmaceutical companies
📩 Interested candidates are encouraged to apply through Teva’s official careers page.
Make your mark in global healthcare with Teva Pharmaceuticals!
