
Regulatory Affairs Officer
ICPA Health Private Limited
Ankleshwar, Gujarat, India
Posted on 01-09-2025
1 Vacancy
Description
- Prepare, compile, and submit dossiers for product registration in domestic and international markets.
- Ensure compliance with regulatory guidelines (CDSCO, USFDA, EMA, WHO, etc.).
- Review technical documents, labels, and packaging for regulatory accuracy.
- Coordinate with R&D, QA, and production teams for regulatory submissions.
- Handle queries and deficiency letters from regulatory authorities.
- Maintain updated knowledge of global regulatory requirements.
- Support product lifecycle management, renewals, and variations.
- Ensure timely approvals for new products and amendments.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Good Communication SkillsAttention to DetailDecision MakingProblem Solving
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