Regulatory Affairs Specialist

Client of Stellar Hunters

We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.

This role requires strong understanding of regulatory frameworks, documentation accuracy and the ability to work cross-functionally in a fast-paced, compliance-driven environment.

• Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).
• Track and manage product registration timelines, renewals, and approvals.

• Ensure all products and processes comply with local and international regulatory requirements.
• Maintain up-to-date regulatory documentation, technical files, and records.

• Monitor changes in regulations and guidelines and assess their impact on the business.
• Communicate regulatory updates to internal stakeholders and recommend necessary actions.

• Work closely with R&D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.
• Support new product development by providing regulatory guidance and requirements.

• Support internal and external audits, inspections, and regulatory inquiries.
• Ensure readiness and proper documentation for compliance reviews.

• Review product labeling, packaging, and marketing materials to ensure regulatory compliance.
• Ensure all product claims are supported and aligned with regulatory standards.

• Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.