Company: Gland Pharma
Industry: Injectables Formulation and Manufacturing, API and Intermediates Research and Manufacturing
Segments: Sterile injectables, oncology, ophthalmic, NCE-1s, First-to-File products, 505b2 filings

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

Job Roles and Responsibilities:

• Text Preparation and Review: Preparation of text matter for artworks/Labels. Review and Approval of Artworks, change controls, and updating for all Regulatory Submissions.
• Labeling Supplements: Preparation and submission of CBE labelling supplements for approved products to USFDA.
• Change Controls: Initiation of Change Controls regarding Artworks, compilation of eCTD modules, and SPL Publication to USFDA.
• Artwork Approval: Approval of commercial artworks in software. Annual establishment registration and BNCC certification & Approval of Print Proofs.
• eCTD Management: Responsible for eCTD Submission, Publication, and product life-cycle management. Responsible for allotting NDC numbers, etc.

How to Apply:
Interested candidates can send their resumes to eswarreddy.ravi@glandpharma.com

Last Date to Apply: 5th August 2024

Feel free to share this posting on various platforms to reach interested candidates.