Regulatory Affairs Executive

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Regulatory Affairs Executive

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

Valence Labs

time outline iconRajpura, Punjab, India

Posted on 20-08-2024

209 Views

1 Vacancy

Description

  • Ensure that all products comply with current regulations and standards, including those related to safety, efficacy, and labeling.
  • Compile and maintain regulatory dossiers, including product information, clinical data, and technical specifications.
  • Maintain accurate and up-to-date records of all regulatory submissions, approvals, and correspondence with regulatory authorities.
  • Manage the renewal and variation of product licenses, ensuring continuous compliance with regulatory requirements.
  • Assist in obtaining regulatory approvals for entering new markets, coordinating with local regulatory agencies and consultants.
  • Develop and execute regulatory strategies for product development, approval, and post-market surveillance.
  • Identify potential regulatory risks and develop mitigation strategies to ensure successful product approvals and market entry.
  • Develop and deliver training programs for internal teams on regulatory requirements, processes, and best practices.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MSc Chemistry

Key Skills

Regulatory ComplianceDocument ManagementMarket ExpansionRegulatory StrategyTraining and Awareness

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