Regulatory Affairs Specialist

Job description

Kinetic has partnered with a leading pharmaceutical company who are actively recruiting a regulatory affairs specialist for their team in Riyadh.

Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.

Main responsibilities

• Prepare, compile, review, and submit regulatory dossiers for new product registrations, renewals, variations, and post-approval changes.
• Work closely with cross-functional teams to facilitate product registrations, lifecycle management activities, and timely approvals.
• Ensure all submissions comply with applicable regulations, guidelines, and company standards.
• Track submission timelines and ensure regulatory commitments are met.

Requirements

• Minimum 3 years of experience in a regulatory affairs role within the pharmaceutical industry.
• Bachelor’s degree in pharmacy, pharmaceutical sciences, life sciences, or a related field.
• Experience in preparing CTD/eCTD submissions.
• Strong knowledge and understanding of pharmaceutical regulatory requirements and guidelines.
• Well experienced in interacting with SFDA.
• Must be based in Riyadh currently.