Regulatory Affairs Officer (Row Market)

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Regulatory Affairs Officer (Row Market)

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

Strava Healthcare Pvt Ltd

time outline iconAhmedabad, Gujarat, India

Posted on 05-08-2025

1 Vacancy

Description

  • Prepare, compile, and submit regulatory dossiers for product approvals to authorities like CDSCO, USFDA, EMA, etc.
  • Ensure that all products comply with local and international regulatory requirements.
  • Review product labeling, packaging, and promotional materials for regulatory compliance.
  • Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards.
  • Liaise with regulatory agencies for approvals, clarifications, and audits.
  • Coordinate with R&D, QA, QC, and production teams to gather data for submissions.
  • Monitor changes in regulations and update internal stakeholders accordingly.
  • Maintain regulatory documentation, licenses, and certificates systematically.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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