Regulatory Affairs Executive

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Regulatory Affairs Executive

work outline icon3 - 5 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Fresenius Kabi Oncology Limited

time outline iconKalyani, West Bengal, India

Posted on 12-12-2024

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1 Vacancy

Description

  • Prepare and submit regulatory documents and applications to ensure compliance with local and international regulatory agencies.
  • Monitor and interpret changes in regulatory laws and guidelines to ensure the company's products remain compliant.
  • Maintain up-to-date knowledge of regulatory requirements for various markets (domestic and international).
  • Coordinate with product development and quality teams to ensure products meet regulatory standards.
  • Review and approve labeling, packaging, and promotional materials to ensure they comply with regulatory guidelines.
  • Manage and track product registrations, licenses, and certifications, ensuring timely renewals.
  • Act as a liaison between regulatory agencies and internal teams, addressing inquiries and concerns.
  • Support regulatory audits and inspections, ensuring documentation and processes are in line with regulatory expectations.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

CommunicationAttention to DetailDecision MakingPositive Attitude

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