Google Job Posting Format:
Position: Manager, Drug Regulatory Affairs (Labelling – US Market)
Company: Gland Pharma
Location: Hyderabad
Industry: Injectables Formulation and Manufacturing, API and Intermediates Research and Manufacturing
Segments: Sterile injectables, oncology, ophthalmic, NCE-1s, First-to-File products, 505b2 filings
Qualifications:
- Education: B.Pharmacy / M.Pharmacy
- Experience: 9 to 12 Years
Key Responsibilities:
| Responsibility | Details |
|---|---|
| Text Preparation and Review | Prepare and review text matter for artworks/Labels. |
| Labeling Supplements | Prepare and submit CBE labeling supplements to USFDA. |
| Change Controls | Initiate change controls for artworks; compile eCTD modules. |
| Artwork Approval | Approve commercial artworks; manage annual registration. |
| eCTD Management | Manage eCTD submissions, NDC numbers, and product lifecycle. |
How to Apply:
Send your resume to eswarreddy.ravi@glandpharma.com
Last Date to Apply: 5th August 2024
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