Regulatory Affairs
Eugia Pharma Specialties Limited
Hyderabad, Telangana, India
Posted on 13-11-2025
1 Vacancy
Description
- Prepare, review, and submit regulatory documents for product approvals and renewals.
- Ensure compliance with national and international regulatory requirements (e.g., CDSCO, USFDA, EMA).
- Maintain up-to-date knowledge of regulatory guidelines and changes.
- Coordinate with R&D, QA, and Production teams for dossier preparation.
- Handle product registration, variations, and post-approval submissions.
- Review labeling, packaging, and promotional materials for compliance.
- Liaise with regulatory authorities and respond to queries in a timely manner.
- Maintain regulatory databases, documentation, and tracking systems.
- Support audits, inspections, and internal compliance initiatives.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Good Communication SkillsAttention to DetailDecision MakingProblem Solving
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