Regulatory Affairs Officer

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Regulatory Affairs Officer

work outline icon3 - 4 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

GMH Organics Private Limited

time outline iconBaddi, Himachal Pradesh, India

Posted on 21-08-2025

1 Vacancy

Description

  • Prepare, review, and submit dossiers, CTD/eCTD, and regulatory documents to authorities.
  • Ensure compliance with national and international drug regulations (USFDA, EMA, WHO, CDSCO, etc.).
  • Coordinate with R&D, QA, QC, and Production teams for regulatory submissions.
  • Handle product registrations, renewals, and variations as per regulatory guidelines.
  • Maintain up-to-date knowledge of changing regulatory requirements.
  • Review labeling, artwork, packaging, and promotional materials for compliance.
  • Support regulatory audits, inspections, and responses to authority queries.
  • Maintain regulatory databases, records, and submission tracking systems.
  • Assist in lifecycle management of products across global markets.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Good Communication SkillsAttention to DetailDecision MakingProblem SolvingTeam working Skills

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