Gland Pharma is one of the fastest-growing small-molecule generic injectables-focused company, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets in the rest of the world. Gland Pharma has seven manufacturing facilities in India, comprising four facilities for finished formulations and three API facilities. We are focused on meeting diverse injectables needs with a stable supply of affordable and high-quality products. We have established a portfolio of injectables products across various therapeutic segments and delivery systems and are present in sterile injectables, oncology and ophthalmics with a focus on complex injectables.
Vacancy details:
- Department:Drug Regulatory Affairs – Deputy Manager / Manager
- Experience: 8 – 12 years
- Qualification: M.Pharma
- Salary:₹ Not Disclosed
Job Description : Greeting from Gland Pharma Pvt Ltd !!!!
Important Details :
- Location: Hyderabad
- Post of date:29/03/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job description
Greetings From Gland Pharma Limited!!!
We are hiring for Drug Regulatory Affairs (Labelling – US Market) Department – Injectables.
Experience : 9 to 12 Years
Qualification : B. Pharmacy / M. Pharmacy
Position : Deputy Manager / Manager
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.
Interested candidates can send their resumes at E-Mail ID: [email protected]
ABAC
