About Gland Pharma

With a global footprint spanning 60 countries, including the United States, Europe, Canada, Australia, India, and other markets, Gland Pharma has developed over the years from a contract manufacturer of low volume liquid parenteral products to one of the largest and fastest growing injectable-focused companies. We have a strong track record in the development, production, and marketing of complicated injectables and predominantly operate on a business to business (B2B) paradigm. Due to our presence throughout the whole value chain, we have experienced exponential growth. Shanghai Fosun Pharma, a significant pharmaceutical company globally, is promoting us.

Exciting Opportunities in Drug Regulatory Affairs (DRA) Department at Gland Pharma Ltd!

Position:

AM/DM/Manager

Experience:

7-10 Years

Qualification:

M. Pharmacy

Location:

Hyderabad

Skills Required:

Drug Regulatory Affairs

Labeling Responsibilities:

Crafting text for artworks/labels and overseeing artwork review and approval.
Managing change controls and ensuring updates for all Regulatory Submissions.
Preparation and submission of CBE 0 labeling supplements for approved products to USFDA.
Initiating Change Controls for Artwork.
Compiling eCTD modules and SPL Publication for USFDA.
Approving commercial artworks in software.
Handling annual establishment registration and BNCC certification, along with Print Proofs Approval.
Managing eCTD Submission, Publication, and product life-cycle.
Allotting NDC numbers.

US Market Responsibilities:

Experience in sterile formulations pre-approvals.

ROW Market Responsibilities:

Experience in handling US or EU market submissions, with a preference for China experience.

Interested candidates can share their updated profiles with us at Eswarreddy.ravi@glandpharma.com.

Join our team and be part of the exciting world of Drug Regulatory Affairs at Gland Pharma Ltd!

For more articles, Kindly Click here.

For pharmaceutical jobs, follow us on LinkedIn

For more jobs, kindly visit our job section.

Job opportunities in Drug Regulatory affairs @ Gland Pharma