Regulatory Affairs Specialist

Job Summary

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.

Key Responsibilities

Regulatory Submissions & Approvals

• 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.

Compliance & Documentation

• Ensure all products and processes comply with local and international regulatory requirements.

• Maintain up-to-date regulatory documentation, technical files, and records.

Regulatory Intelligence

• Monitor changes in regulations and guidelines and assess their impact on the business.

• Communicate regulatory updates to internal stakeholders and recommend necessary actions.

Cross-functional Collaboration

• 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.

Audit & Inspection Support

• Support internal and external audits, inspections, and regulatory inquiries.

• Ensure readiness and proper documentation for compliance reviews.

Labeling & Claims Review

• Review product labeling, packaging, and marketing materials to ensure regulatory compliance.

• Ensure all product claims are supported and aligned with regulatory standards.

Continuous Improvement

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

Required Qualifications - Skills & Experience

• Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related field.

• 2–5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.

• Strong knowledge of regulatory frameworks and submission processes.

• Experience with product registration and regulatory documentation.

• Excellent attention to detail and organizational skills.

• Strong communication and stakeholder management skills.

Preferred Qualifications

• Experience with Saudi regulatory bodies such as SFDA .

• Familiarity with GCC or international regulatory requirements.

• Experience with electronic submission systems and regulatory databases.

• Certification or training in regulatory affairs is a plus.

Work Environment & Compensation

• Full-time position with an onsite model.

• Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.

• Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.

• Inclusive culture that values diversity, equity, work-life balance, and employee well-being.