Posted:3 weeks ago|
Platform:
On-site
Full Time
Responsibilities include, but are not limited to:
Ø Regulatory support for assigned projects through product development and lifecycle management of products for US market.
Ø Prepare technical documents required for submission of dossier as per country specific requirements.
Ø Prepare, develop, and maintain internal Regulatory informational trackers.
Ø Review and approve labels inline with US regulatory requirements for assigned products.
Ø Respond to consumer inquiries based on approved labels and product information.
Ø Coordinate the receipt of raw material regulatory documents from vendors.
Ø Preparation of module 1 sections including labelling sections for ANDA products.
Ø Perform drug listing of assigned products for US market.
Ø Support publishing of ANDA submissions including SPL Creation.
Ø Support manufacturing site for commercialization and life cycle management of the approved products.
Ø Other projects and duties as assigned by Senior Management
Job Type: Full-time
Pay: ₹15,000.00 - ₹25,000.00 per month
Work Location: In person
Contract Pharmacal Corp.
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ahmedabad, gujarat
Experience: Not specified
1.8 - 3.0 Lacs P.A.
ahmedabad, gujarat
Experience: Not specified
1.8 - 3.0 Lacs P.A.
