Description
Job Summary:
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.