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Regulatory Affairs - Executive / Asst. Manager

Regulatory Affairs - Executive / Asst. Manager

Aneta Pharmaceuticals

4 - 8 years

4 - 6 Lacs

ahmedabad

Posted:9 hours ago| Platform:

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Skills Required

regulatory compliance qa qc production cis

Work Mode

Work from Office

Job Type

Full Time

Job Description

1.Prepare, compile, and review regulatory dossiers for submission in ROW/EU/CIS markets.
2.Ensure timely submission of product registration dossiers in compliance with applicable regional regulatory requirements.3.Liaise with health authorities, partners, and internal cross-functional teams for query responses and updates.4.Monitor changes in regulatory guidelines and proactively assess impact on product lifecycle.5.Support renewal and variation submissions for existing products.6.Coordinate with internal departments such as QA, QC, R&D, and Production for required documentation.7.Maintain regulatory databases and documentation in an organized and audit-ready manner.8.Ensure compliance with all local and international regulatory requirements and company standards.

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Regulatory Affairs - Executive / Asst. Manager