Regulatory Affairs Supervisor

2 weeks ago


Riyadh, Ar Riyāḑ, Saudi Arabia MS Pharma Injectable Full time

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The Regulatory Affairs Supervisor is responsible for preparing registration dossiers for new products, line extensions, and new indications. They will also be responsible for maintaining the license of existing registered products by managing all regulatory activities throughout the product lifecycle.

Main Responsibilities:

  • Build and maintain good relationships with Health Authorities.
  • Stay informed about all regulatory guidelines and requirements at the national level.
  • Prepare all necessary documents for new registrations, line extensions, new indications, and relevant maintenance activities.
  • Prepare documents for NDA & Generic/LCM activities in a timely manner.
  • Ensure readiness for submission of regulatory documents as per strategy.
  • Track and manage product information updates to ensure successful implementation.
  • Create artworks in line with approved information by Health Authorities.
  • Inform relevant stakeholders about effective information updates.
  • Adhere to local and global SOPs during daily regulatory activities.
  • Monitor global compliance reports and work on continuous improvement.
  • Prioritize submissions and approvals of key regulatory activities.
  • Coordinate with Global/Regional Brand Regulatory Managers and other relevant functions.
  • Collaborate and align with other local cross-functions to ensure regulatory requirements are met.
  • Maintain Regulatory Information Management systems and databases with updated data.
  • Archive regulatory documents properly and timely.
  • Complete assigned training within the provided timeframe.
  • Collaborate and support other team members to achieve team goals.

Requirements:

  • Bachelor's degree in pharmacy or equivalent degree.
  • 2-4 years of regulatory experience
  • Proficiency in written, read and spoken Arabic and English Languages
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