Regulatory Affairs Executive

Regulatory Affairs Executive

work outline icon4 - 6 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Lyka Labs Ltd

time outline iconAnkleshwar, Gujarat, India

Posted on 28-07-2025

1 Vacancy

Description

  • Prepare, compile, and submit regulatory dossiers for domestic and international markets.
  • Coordinate with cross-functional teams (QA, QC, R&D, Production) for technical documentation.
  • Ensure timely submission and follow-up for product registration, renewals, and variations.
  • Review labeling, packaging, and promotional materials for regulatory compliance.
  • Respond to queries and deficiency letters from regulatory authorities.
  • Maintain up-to-date knowledge of global regulatory requirements (CDSCO, USFDA, EMA, etc.).
  • Ensure documentation as per CTD, ACTD, or eCTD formats.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MSc (Master of Science)MPharm (Master Of Pharmacy)BSc (Bachelor of Science)BPharm (Bachelor Of Pharmacy)

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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