Regulatory Affairs Officer

Regulatory Affairs Officer

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

SP Accure Labs Pvt Ltd

time outline iconMedchal Malkajgiri, Telangana, India

Posted on 11-12-2025

1 Vacancy

Description

  1. repare, review, and submit regulatory documents for product approvals and renewals.
  2. Ensure compliance with national and international regulatory guidelines (CDSCO, FDA, WHO, EMA, etc.).
  3. Coordinate with R&D, QA, QC, and Production teams to gather required technical data.
  4. Maintain product dossiers, CTD/eCTD files, and regulatory databases.
  5. Review product artwork, labels, and packaging for regulatory accuracy.
  6. Track regulatory changes and update internal teams on new requirements.
  7. Handle product registration, license applications, and variations.


Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Decision-MakingAttention to DetailGood Communication SkillsProblem Solving

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