Gland Pharma Opportunity For Regulatory Affairs (DRA) And Multiple Drug Development

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: dra drugregulatoryaffairs

Labeling sterileforumations usmarket china

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 O 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

to Eswarreddy.ravi@glandpharma.com