Regulatory Affairs

Regulatory Affairs

work outline icon3 - 8 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

SP Accure Labs Pvt Ltd

time outline iconHyderabad, Telangana, India

Posted on 13-05-2025

1 Vacancy

Description

  • Prepare, compile, and review CTD/eCTD/ACTD dossiers for product registration in domestic and international markets
  • Ensure timely submission of applications for new product approvals, renewals, and variations
  • Coordinate with R&D, QA, QC, and manufacturing teams for technical documentation and data
  • Respond to queries and deficiency letters from regulatory authorities
  • Maintain up-to-date knowledge of current regulations, guidelines, and procedures
  • Monitor regulatory status of products and ensure compliance with labeling and packaging regulations
  • Handle post-approval changes, renewals, and periodic updates as per market-specific requirements
  • Track registration status and manage regulatory databases and documentation systems
  • Ensure that promotional and packaging materials comply with regulatory norms
  • Participate in internal and external audits related to regulatory documentation

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Attention to DetailCommunicationTeam WorkPositive Attitude

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