Hiring for Drug Regulatory Affairs at Gland Pharma - B.Pharm, M.Pharm Apply

Gland Pharma is the worlds leading player in Injectables Formulation and Manufacturing. It is also into API and Intermediates research and manufacturing. Gland Pharma is present in sterile injectables, oncology and ophthalmic segments, and focus on complex injectables including NCE-1s, First-to-File products and 505b2 filings.

Hiring for Drug Regulatory Affairs (Labelling - US Market) Department

Post : Manager

Experience : 9 to 12 Years
Qualification : B.Pharmacy / M.Pharmacy
Job Location : Hyderabad.
Job Roles : DRA - Labelling US Market.
• Preparation of text matter for artworks/Labels. Review and Approval of Artworks, change controls and updating for all Regulatory Submissions.
• Responsible for preparation and submission of CBE labelling supplements for approved products to USFDA.
• Initiation of Change Controls regarding Artworks, compilation of eCTD modules and SPL Publication to USFDA.
• Approval of commercial artworks in software. Annual establishment registration and BNCC certification & Approval of Print Proofs.
• Responsible for eCTD Submission, Publication and product life-cycle management. Responsible for allotting NDC numbers, etc.