Deputy Manager-Regulatory Affairs

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Deputy Manager-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

  • Lead and manage regulatory submissions for domestic and international markets (CTD/eCTD).
  • Oversee product registrations, renewals, variations, and regulatory approvals.
  • Ensure compliance with global regulatory guidelines (USFDA, EMA, MHRA, WHO, CDSCO, etc.).
  • Act as a liaison with health authorities and handle regulatory inspections and audits.
  • Review and approve technical documents, labeling, artwork, and promotional materials.
  • Develop and implement regulatory strategies for new product development and lifecycle management.
  • Coordinate with R&D, QA, QC, and Production teams for timely documentation.
  • Guide, mentor, and train junior staff in regulatory processes and best practices.
  • Maintain and update regulatory records, SOPs, and databases as per standards.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

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

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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