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

Gland Pharma Limited is Hiring Drug Regulatory Affairs (Labelling – US Market)
HyderabadB. Pharmacy / M. Pharmacy

Hiring for Drug Regulatory Affairs (Labelling – US Market)

Job Position  : DRA – Labelling US Market

Experience : 6 to 9 Years

Qualification : B. Pharmacy / M. Pharmacy

Job Location : Hyderabad.

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.

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

 

About Gland Pharma Limited

Founded in 1978 in Hyderabad, India, Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenterals into one of the world’s leading and fastest-growing producers of generic injectables, serving over 60 countries, including the US, Europe, Canada, Australia, and India. Operating under a primarily B2B model, Gland Pharma has built a strong reputation for excellence in R&D, manufacturing, and marketing of complex injectable pharmaceuticals. Our end-to-end presence in the pharmaceutical value chain has fueled our rapid and sustained growth over the years. Gland Pharma boasts a professional leadership team, with Shanghai Fosun Pharma, a major global pharmaceutical company, as one of its key promoters. Our core therapeutic areas include sterile injectables, oncology, and ophthalmology, with a focus on complex formulations such as NCE-1s, First-to-File products, and 505(b)(2) applications. We currently offer our injectables in various formats, including liquid and lyophilized vials, pre-filled syringes, ampoules, infusion bags, and eye drops. To expand our capabilities, we are actively investing in the development of advanced formulations, including peptides, long-acting injectables, hormonal products, and suspensions. As part of our pipeline expansion, we are also introducing innovative delivery systems like pens and cartridges to better meet diverse patient needs.

Job Overview

Location: Hyderabad

Qualification: B. Pharmacy / M. Pharmacy

Experience: 6-9 Years