Join JAMP Pharma’s Regulatory Affairs Team – Careers in Pharma
About Company
Ensure Pharma Technologies is a cost effective and aggressive contract research firm. We have our to develop a wide range of complex ANDA, novel ANDA, and para IV ANDA to comply with a most aggressive timeline.
The challenge of accelerating product development while controlling costs is a difficult balancing act for the generic pharmaceutical industry. Our scientific capabilities are complete and integrated. Our capabilities can deliver end-to-end solutions that fit precisely with our client needs, irrespective of the size or complexity of their undertakings. Our expertise in the area of cost effective pharmaceutical development, efficient clinical studies partnering, compliance, regulatory affairs, patent landscaping and developing non-infringement technology, and eCTD preparation along with submission to various agencies can provide a “one stop” strategic advantage to our clients
We provide a broad range of regulatory and compliance expertise with comprehensive project management to ensure that each development project meets US FDA, MHRA, EMEA and other global regulatory standards including QbD expectations.
Our CMC (Chemistry, Manufacturing, and Control) expertise includes controlling technical operations concerning drug development including at R & D, manufacturing, and at BE center. Our technical expertise includes effective management of technical operations at R & D, manufacturing, for QMS (Quality Management Systems), physical and chemical characterization, pre-formulation, formulation, API sourcing and development of product line extension based on non-infringing technologies.
REGULATORY AFFAIRS – eCTD
Officer / Senior Officer / Executive
Key Responsibilities:
• eCD Compilation, validation, and submission to Health Canada and US through ESG gateway for : New Submission (ANDS/NDS), Deficiencies response (Clarifax, SDN, NOD, NON etc.), Supplements submissions (SANDS, ARs, Safety updates, RMPs etc.).
• eCTD Compilation, validation, and submission to export market.
• eCTD lifecycle management of products.
• Maintaining daily submission tracking.
• Implementing & Maintaining Document Management System.
Specifications:
• Department: Regulatory Affairs – eCTD
• Experience: 1 – 5 years
• Qualification: B. Pharma / M. Pharma / M.Sc
• Location: Ahmedabad
Send profile at
sjani@jamppharma.com
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