Regulatory Affairs Executive (Row Market)

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Regulatory Affairs Executive (Row Market)

work outline icon1 - 3 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Strava Healthcare Pvt Ltd

time outline iconAhmedabad, Gujarat, India

Posted on 05-08-2025

1 Vacancy

Description

  • Prepare, compile, and submit regulatory dossiers for product registration in RoW markets (Africa, Asia, LATAM, CIS, etc.).
  • Review and collate technical documents like COA, COPP, CPP, FSC, stability data, and product specifications.
  • Coordinate with cross-functional teams (R&D, QA, QC, Production) to gather and validate required documents.
  • Ensure compliance with the specific regulatory requirements of each target country.
  • Track and manage product registration timelines, renewals, and post-approval changes.
  • Respond to regulatory queries and deficiencies raised by local health authorities.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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