Regulatory Affairs

Regulatory Affairs

work outline icon1 - 3 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Eugia Pharma Specialties Limited

time outline iconHyderabad, 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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