Regulatory Affairs Associate I - Teva Pharmaceuticals

Regulatory Affairs Associate I - Teva Pharmaceuticals

📍 Location: Navi Mumbai, India
🏢 Company: Teva Pharmaceuticals
🆔 Job ID: 62820
📅 Date Posted: July 9, 2025


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🧾 About the Company:

Teva Pharmaceuticals is a global leader in generic medicines and a key contributor to the World Health Organization’s Essential Medicines List. With a presence in nearly 60 countries and touching over 200 million lives daily, Teva is on a mission to make healthcare more affordable and accessible worldwide.


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🧩 Job Role: Regulatory Affairs Associate I

This role involves preparing and reviewing US generic labeling documents (ANDA/505(b)(2)) under direct supervision. The selected candidate will ensure all materials comply with US FDA regulations and contribute to drug listing processes through SPL preparation.


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🛠️ Key Responsibilities:

Prepare and revise high-quality labeling documents (US Gx) for ANDA and/or 505(b)(2) submissions.

Develop and maintain Structured Product Labeling (SPL) files and ensure full drug listing compliance.

Electronically compile FDA responses with side-by-side comparisons, SPLs, and required documents.

Proofread labeling files using manual checks or electronic tools like TVT.

Coordinate with Regulatory Operations to ensure submissions meet eCTD and deadline requirements.

Stay updated with FDA guidelines, regulations, and SOPs.

Collaborate in a team environment and handle additional responsibilities as assigned.



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🎓 Qualifications:

Education:

Bachelor’s in Pharmacy / Master’s in Science & Life Sciences with 2–3 years of industry experience

OR Master’s in Pharmacy with 1–3 years of industry experience


Experience & Skills:

Hands-on experience in regulatory affairs focused on US generic labeling

Knowledge of SPL creation and FDA submission standards (eCTD)

Strong written and verbal communication skills

Proficiency in MS Word, Excel, Adobe Acrobat Pro; familiarity with TVT preferred

Attention to detail, multitasking ability, and independent work ethic




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📝 How to Apply:

To know more about job details & to apply, visit here:


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📌 Disclaimer:

This post is for informational purposes only. 9ledge Craft is not a hiring partner for this role. Please visit the official website of the organization to apply and for the most accurate details. We do not have control over the hiring process.

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