Executive/Sr. Executive-Regulatory Affairs

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Executive/Sr. Executive-Regulatory Affairs

work outline icon2 - 12 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Axxelent Pharma Science Private Limited, Chennai

time outline iconChennai, Tamil Nadu, India

Posted on 03-09-2025

1 Vacancy

Description

  • Prepare, review, and submit regulatory documents (CTD/eCTD, dossiers) to health authorities.
  • Ensure compliance with national and international regulatory requirements.
  • Coordinate with R&D, QA, QC, and Production teams for data collection and document preparation.
  • Maintain updated knowledge of global regulatory guidelines (USFDA, EMA, MHRA, CDSCO, etc.).
  • Handle product registration, renewals, variations, and licensing activities.
  • Respond to queries from regulatory agencies within defined timelines.
  • Review labeling, packaging, and promotional materials for regulatory compliance.
  • Support audits and inspections by regulatory authorities.

Category

Pharmaceuticals

Preferred Education

MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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