Regulatory Associate

  • Full-time
  • Job Family: Regulatory Affairs
  • Sub Job Family: Regulatory Affairs General
  • Preferred type of working: On-Premise
  • Years of Experience: 1 - 3
  • Business unit: Biologics

Job Description

  1. Preparation of applications and submission packages for various biologics/biosimilars regulatory submissions.
  2. Authoring master and country specific dossier sections according to CTD module
  3. Review of CMC technical documents required for submissions and ensure compliance with regulations and guidance
  4. Updating and maintaining regulatory databases and ensure regulatory compliance
  5. Familiar/Hands on with regulatory submission software’s including eCTD, RIMS etc
  6. Assessment of the Change Controls against variation guidelines
  7. Preparing, reviewing and submitting renewal documents/ renewal dossiers/ variations/responding to queries raised by Ministry of Health

Qualifications

  • Must have a master/professional degree in scientific discipline.
  • Must have 3+ years of hands-on relevant technical or regulatory experience within the biotechnology industry.
  • Proficiency in MS Office applications.
  • Detail-oriented, ability to learn, plan and work in a dynamic team environment.
  • Must have excellent communication (written and verbal), collaboration, and problem-solving skills
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