Amina GACEM

Skills

• Regulatory Affairs (AMM, Variations, Renewals)
• Quality Assurance
• Internal Audits & Compliance
• ISO 9001, GMP, ICH Guidelines
• SOP Creation & Revision
• PPI Preparation & Regulatory Submissions
• Cross-functional Coordination
• Problem-solving & Communication Skills

About

With over 5 years of experience in the pharmaceutical industry, I’ve developed strong expertise in regulatory affairs and technical management, ensuring compliance throughout the entire product lifecycle; from development and registration to post-marketing.

My role involves overseeing regulatory strategies, maintaining product quality and safety, and supporting the successful market access of pharmaceutical products.

I’m passionate about aligning scientific rigor with regulatory excellence to drive innovation and sustainable growth within the healthcare sector.