Company: Teva Pharmaceuticals
Location: Mumbai & Bangalore
Experience: 7-9 years (6+ years in Regulatory Affairs preferred)
Qualification: B.Pharm/M.Pharm/M.Sc in Life Sciences
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to improving health and increasing access to quality healthcare solutions. With a strong presence in over 60 countries, Teva focuses on innovative treatments and high-quality generics, ensuring better patient outcomes worldwide.
Job Description
Key Responsibilities:
- Develop US labeling documents for ANDAs and 505(b)(2) submissions, ensuring compliance with FDA regulations.
- Create carve-out labeling content for patents/exclusivities.
- Serve as a Subject Matter Expert (SME) in Structured Product Labeling (SPL) and drug listing, ensuring alignment with FDA guidelines.
- Collaborate with the SPL Vendor and FDA Drug Listing Team to resolve issues promptly.
- Prepare and submit eCTD-compliant responses to the FDA, including side-by-side comparisons and SPL updates.
- Conduct quality reviews of labeling documents using electronic proofreading tools like TVT.
- Work closely with CMC, Device Teams, and Regulatory Operations to align labeling strategies.
- Support Business Development projects from a labeling and drug listing perspective.
- Maintain an accurate project tracker to ensure timely submissions.
- Assist in year-end FDA Mandated Blanket No Change certification to keep drug listings active.
- Train new team members and stay updated on US FDA labeling regulations.
Skills & Qualifications:
- 7-9 years in the pharmaceutical industry, with 6+ years in US Regulatory Affairs (Labeling & Drug Listing).
- Strong knowledge of FDA eCTD submission standards, SPL, and US Gx labeling.
- Proficiency in Microsoft Office, Adobe Acrobat, and Structured Product Labeling software.
- Ability to multi-task in a fast-paced environment.
- Excellent proofreading, editing, and formatting skills.
How to Apply
Interested candidates can share their updated CV to:
📧 ankita.sonawane@teva.co.in