Company: Gland Pharma Pvt Ltd
Job Position: DRA – Labelling (US Market)
Experience: 6 to 9 Years
Qualification: B.Pharmacy / M.Pharmacy
Job Location: Hyderabad
Interview Date: May 2025 (Walk-in)
Selection Process: Face-to-Face Interview (HR Round)
How to Apply: Send your updated CV to saranya.ramesan@glandpharma.com
Job Description: Drug Regulatory Affairs (Labelling – US Market) at Gland Pharma
Gland Pharma Limited, a leading pharmaceutical company, is hiring experienced professionals for Drug Regulatory Affairs (Labelling – US Market) in Hyderabad. This is an excellent opportunity for candidates with 6-9 years of experience in USFDA labelling compliance and regulatory submissions.
Key Responsibilities:
- Preparation, review, and approval of artworks/labels for US market compliance.
- Submission of CBE 0 labelling supplements for approved products to USFDA.
- Handling Change Controls related to artworks and updating regulatory submissions.
- Compilation of eCTD modules and SPL (Structured Product Labeling) publication for USFDA.
- Approval of commercial artworks and print proofs.
- Managing annual establishment registration and BNCC certification.
- Allocating NDC numbers and ensuring compliance with USFDA regulations.
- Overseeing product life-cycle management in regulatory submissions.
About Gland Pharma Limited
Gland Pharma is a global pharmaceutical company specializing in injectable formulations. With a strong presence in the US market, the company is known for its high-quality generic injectables, biotechnology products, and complex formulations. Gland Pharma is committed to innovation, compliance, and regulatory excellence, making it a preferred employer for professionals in the pharmaceutical industry.
How to Apply for Gland Pharma Walk-in Interview 2025?
Interested and eligible candidates can send their updated CV to saranya.ramesan@glandpharma.com with the subject line “Application for DRA – Labelling (US Market)”.
Selection Process:
- Interview Mode: Face-to-Face
- Interview Rounds: HR Round
- Venue: Hyderabad (Details will be shared via email)