Regulatory Affairs Executive
Lyka Labs Ltd
Ankleshwar, Gujarat, India
Posted on 28-07-2025
1 Vacancy
Description
- Prepare, compile, and submit regulatory dossiers for domestic and international markets.
- Coordinate with cross-functional teams (QA, QC, R&D, Production) for technical documentation.
- Ensure timely submission and follow-up for product registration, renewals, and variations.
- Review labeling, packaging, and promotional materials for regulatory compliance.
- Respond to queries and deficiency letters from regulatory authorities.
- Maintain up-to-date knowledge of global regulatory requirements (CDSCO, USFDA, EMA, etc.).
- Ensure documentation as per CTD, ACTD, or eCTD formats.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MSc (Master of Science)MPharm (Master Of Pharmacy)BSc (Bachelor of Science)BPharm (Bachelor Of Pharmacy)
Key Skills
Attention to DetailCommunicationTeam WorkProblem Solving
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