Gland Pharma Pvt Ltd is Hiring for Drug Regulatory Affairs (Labelling – US Market)

Gland Pharma Limited is Hiring for Drug Regulatory Affairs (Labelling – US Market)

Roles & Responsibilities:-

• 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 0 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.

📩 How to Apply:

Send your updated CV to saranya.ramesan@glandpharma.com