Regulatory Affairs Manager

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Regulatory Affairs Manager

work outline icon0 - 5 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Lord's Mark Biotech

time outline iconMumbai, Maharashtra, India

Posted on 25-01-2024

584 Views

1 Vacancy

Description

  • Develop and implement regulatory strategies to ensure compliance with national and international regulations.
  • Provide strategic input during product development to address regulatory requirements from the outset.
  • Prepare and submit regulatory documents, applications, and dossiers to regulatory agencies for product approvals, registrations, and certifications.
  • Ensure timely and accurate submission of required documents.
  • Monitor and interpret changes in regulatory requirements and inform relevant departments of their impact.
  • Conduct internal audits to ensure ongoing compliance with regulatory standards.
  • Act as the primary point of contact with regulatory agencies.
  • Respond to inquiries and requests for additional information from regulatory authorities.
  • Ensure that product labels and packaging comply with regulatory requirements.
  • Review and approve labeling content for accuracy and compliance.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Regulatory StrategyRegulatory SubmissionsCompliance MonitoringPackaging ComplianceRegulatory Training

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