Regulatory Affairs Specialist📣 Job Ad

About the Opportunity

Kinetic Business Solutions is collaborating with a reputable pharmaceutical company to recruit a Regulatory Affairs Specialist. This full-time position is based in Riyadh, Saudi Arabia, offering an opportunity to contribute to regulatory compliance and product lifecycle management within the pharmaceutical industry.

Role Purpose

The Regulatory Affairs Specialist plays a critical role in ensuring that all pharmaceutical products comply with applicable local and international regulatory standards. This involves managing the submission process for new products, renewals, and changes, working closely with various internal teams to achieve timely approvals and maintain regulatory commitments.

Key Responsibilities

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

Qualifications and Experience

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
• Minimum of 3 years of experience in a Regulatory Affairs role within the pharmaceutical industry.
• Demonstrated experience in preparing CTD/eCTD submissions.

Essential Knowledge and Interaction

• Strong knowledge and understanding of pharmaceutical regulatory requirements and guidelines.
• Proven experience interacting with the Saudi Food and Drug Authority (SFDA).

Work Setting

This is a full-time position based in Riyadh, Saudi Arabia, offering an opportunity to work within a dynamic pharmaceutical environment focused on regulatory excellence.