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CMC REGULATORY AFFAIRS SPECIALIST

CMC REGULATORY AFFAIRS SPECIALIST

Katalyst HealthCares and Life SciencesCary, NC, United States
30+ days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Regulatory Submission : Prepare and submit documents to regulatory authorities, including Investigational New Drug (IND) applications and Abbreviated New Drug Applications (ANDA).
  • Compliance Monitoring : Ensure that clinical trials adhere to Good Clinical Practice (GCP) and other relevant regulations.
  • Communication : Act as a liaison between regulatory bodies, clinical teams, and external stakeholders to facilitate communication and address any compliance issues.
  • Document Management : Maintain and organize essential documents, including study protocols, informed consent forms, and safety reports.
  • Risk Assessment : Identify potential regulatory risks and develop strategies to mitigate them throughout the clinical trial process.
  • Training and Support : Provide guidance and training to clinical research staff on regulatory requirements and best practices.
  • Stay Updated : Keep abreast of changes in regulatory policies and guidelines that may impact clinical research.

Requirements :

  • Knowledge of Regulations : In-depth understanding of FDA regulations, ICH guidelines, and other international regulations.
  • nalytical Skills : Ability to analyse complex regulatory documents and data.
  • ttention to Detail : Meticulous in reviewing documents for accuracy and compliance.
  • Communication Skills : Strong written and verbal communication skills for effective interaction with diverse stakeholders.
  • Project Management : Ability to manage multiple projects and timelines efficiently.
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    Regulatory Specialist • Cary, NC, United States