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UNIZA GROUP
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Regulatory Affairs Executive

Regulatory Affairs Executive

2 years

|

1 - 0 Lacs

science city ahmedabad gujarat

Posted:23 hours ago| Platform: SimplyHired logo

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Skills Required

master's degree in-person

Work Mode

On-site

Job Type

Full Time

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

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