Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. We operate primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectables. This presence across the value chain has helped us witness exponential growth. We are promoted by Shanghai Fosun Pharma, a global pharmaceutical major.
Greetings from Gland Pharma Ltd!!!
We have multiple vacancies in Drug Regulatory Affairs (DRA) department for Labeling, US Market & ROW or China.
- Designation : AM / DM / Manager.
- Experience : 7 – 10 Years
- Qualification : M. Pharmacy
- Location : Hyderabad.
Skills Required: Drug regulatory affairs
1. For Labeling:
· 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 labeling 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.
2. For US Market:
Required experience in sterile formulations pre-approvals.
3. For ROW Market:
Experience in handling US or EU market submissions, China experience is much preferred.
Interested candidates can share their updated profile to [email protected]
