Exciting Opportunity in Drug Regulatory Affairs at Gland Pharma- Apply before 5th August 2024

Join the Leading Player in Injectables Formulation and Manufacturing

Position: Manager – Drug Regulatory Affairs (Labelling – US Market)
Experience: 9 to 12 Years
Qualification: B.Pharmacy / M.Pharmacy
Location: Hyderabad

About Gland Pharma

Gland Pharma is a global leader in injectables formulation and manufacturing, specializing in sterile injectables, oncology, and ophthalmic segments. The company focuses on complex injectables, including NCE-1s, First-to-File products, and 505(b)(2) filings. In addition to formulations, Gland Pharma is also involved in API and intermediates research and manufacturing.

Job Roles and Responsibilities

• Text Preparation: Create text matter for artworks/labels and review and approve artworks and change controls for all regulatory submissions.
• CBE Labelling Supplements: Prepare and submit CBE labelling supplements for approved products to the USFDA.
• Change Controls: Initiate change controls regarding artworks, compile eCTD modules, and publish SPL to USFDA.
• Commercial Artworks Approval: Approve commercial artworks in software, manage annual establishment registration, BNCC certification, and approve print proofs.
• eCTD Submission: Oversee eCTD submission, publication, and product lifecycle management, including allotting NDC numbers.

How to Apply

Interested candidates are encouraged to send their resumes to eswarreddy.ravi@glandpharma.com.

Last Date to Apply: 5th August 2024

Join Gland Pharma and be a part of a team that’s shaping the future of pharmaceuticals!

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