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
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