Gland Pharma has expanded significantly from its origins as a contract manufacturer of small volume liquid parenteral products to emerge as a leading injectable-focused company. With a presence in 60 countries worldwide, including key markets such as the United States, Europe, Canada, Australia, and India, we primarily operate under a business to business (B2B) model. Our strong reputation is built on our expertise in developing, manufacturing, and marketing complex injectables.
Greetings From Gland Pharma Limited!!!
We are hiring for Drug Regulatory Affairs (Labelling – US Market) Department – Injectables.
Regulatory Affairs (Labelling – US Market) – Injectables.
Experience : 9 to 12 Years
Qualification : B. Pharmacy / M. Pharmacy
Position : Deputy Manager / Manager
Job Location: Hyderabad.
Job Roles: DRA- Labelling (US Market)
Job Description:
- 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: eswarreddy.ravi@glandpharma.com
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