Job Description

Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA /MAA). Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation. Submit applications to US FDA, EMA, and other authorities in compliance with regional requirements. Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent. Ensure completeness and technical accuracy of eCTD sequences. Troubleshoot validation issues before final submission. Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes). Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA's PAS, EMA's Type IA/IB/II). Collaborate with internal departments to gather data and draft scientifically sound responses. Stay updated with changes in FDA, EMA, and ICH guidelines. Maintain regulatory databases, submission trackers, and approval records. Participate in audits and support regulatory inspections.
Job Type: Full-time

Pay: ?30,000.00 - ?50,000.00 per month

Benefits:

Paid sick time Paid time off
Schedule:

Day shift UK shift
Application Question(s):

Product registration and post licence changes experience in Regulated market must required.
Experience:

Regulated Market : 3 years (Required) Health Canada/ US/EU: 3 years (Required)
Location:

Gota, Ahmedabad, Gujarat (Required)
Work Location: In person