Assistant/Deputy Manager – Regulatory Affairs

About the Job

Requirements:

  1. Bachelor’s / Master’s in Pharmacy or relevant discipline.
  2. 4-7 years of experience in Regulatory Affairs within the pharmaceutical industry.
  3. Strong understanding of DRAP regulations & registration procedures.
  4. Excellent coordination and documentation skills.
  1. Bachelor’s / Master’s in Pharmacy or relevant discipline.

  2. 4-7 years of experience in Regulatory Affairs within the pharmaceutical industry.

  3. Strong understanding of DRAP regulations & registration procedures.

  4. Excellent coordination and documentation skills.

Key Responsibilities:

  • Prepare and review regulatory dossiers for product registration and renewals.
  • Liaise with DRAP and other regulatory bodies to ensure timely submissions and approvals.
  • Monitor changes in regulatory requirements and ensure compliance with local laws.
  • Maintain updated documentation and coordinate with cross-functional teams for regulatory activities.
  • Support audits, inspections, and respond to regulatory queries effectively.
  • Prepare and review regulatory dossiers for product registration and renewals.

  • Liaise with DRAP and other regulatory bodies to ensure timely submissions and approvals.

  • Monitor changes in regulatory requirements and ensure compliance with local laws.

  • Maintain updated documentation and coordinate with cross-functional teams for regulatory activities.

  • Support audits, inspections, and respond to regulatory queries effectively.