Job Description

Prepare, review, and compile

dossiers (CTD / ACTD format)

for international markets (e.g., EU, Africa, Asia, LATAM, CIS, GCC). Coordinate with

R&D, QA, QC, Production, and Packaging

teams for document collection and query resolution. Ensure submission of high-quality regulatory documentation in compliance with

country-specific guidelines

. Handle

post-approval variations, renewals, and regulatory updates

as per agency requirements. Maintain and update

regulatory tracking databases

and documentation systems. Liaise with

international regulatory authorities and partners

for submissions and query responses. Support the

labeling, artwork review, and product information updates

in accordance with regulatory standards. Monitor

regulatory changes

and communicate impacts to internal teams. Review of the technical documents like BMR, Specification, Method of analysis, COA for Raw material, packing material and finished product Maintain the FDA license documentation like Product permission, CoPP, FSC and related expenses
Job Types: Full-time, Permanent

Pay: ?12,212.26 - ?30,000.00 per month

Benefits:

Health insurance Leave encashment Paid sick time Provident Fund
Ability to commute/relocate:

Science City, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)
Education:

Master's (Preferred)
Experience:

Regulatory Affairs: 2 years (Required) Dossier Preparing: 2 years (Required) FDA regulations: 2 years (Required)
Location:

Science City, Ahmedabad, Gujarat (Preferred)
Work Location: In person