Nadia Kassem
Compliance Officer @Cellchem Pharmaceuticals Inc
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WORK HISTORY
Compliance Officer @Cellchem Pharmaceuticals Inc
Ottawa, ON, CA
Quality Control (QC):•Develop and maintain a robust quality management system that complies with GMP guidelines to ensure the integrity and safety of pharmaceutical products.•Manage the review and upkeep of quality documentation for finished products and active pharmaceutical ingredients (API) from various manufacturers.•Draft and manage critical quality-related documents including SOPs, Site Master Files, and CAPA reports, ensuring adherence to Natural Health Products regulations.•Facilitate internal audits and inspections, enhancing compliance with regulatory standards and supporting continuous improvement in product quality.Regulatory Affairs (RA):•Design and execute regulatory strategies that maximize product approval timelines while ensuring compliance with Health Canada regulations.•Lead the preparation and submission of regulatory documents for new licenses and product renewals, including ANDAs, NDAs, and MAAs.•Maintain an up-to-date record of all regulatory submissions and interactions, ensuring alignment with evolving regulatory requirements.•Collaborate with cross-functional teams to integrate regulatory requirements throughout the product lifecycle, enhancing regulatory compliance and operational efficiency.
EDUCATION
Algonquin College of Applied Arts and Technology
Postgraduate Degree
Algonquin College International Education Centre
Occupation-Specific Language Training
YogaFit
Ayurvedic Lifestyle Coach
Yogafirst
RYT 500 hours
Tishreen University
Bachelor's degree
MEFITPRO
Group Exercise Leader
ABOUT NADIA KASSEM
Nadia Kassem is a dedicated pharmacist with a passion for regulatory affairs, policy analysis, and pharmacovigilance. Her expertise spans across pharmaceuticals, natural health products (NHPs), food, and agrochemicals, where she has gained valuable experience in ensuring products meet stringent regulatory standards, prioritizing public health and safety. Throughout her career, Nadia has demonstrated adaptability and a strong collaborative spirit, working with diverse teams and navigating complex regulatory landscapes. Her education in the Regulatory Affairs Sciences program included hands-on experience with Health Canada, FDA regulations, the Food and Drug Act, Safe Food for Canadians Regulations, and GMP equipping her with a solid foundation to excel in the industry. With a Bachelor’s degree in Pharmacy and a Postgraduate Certificate in Regulatory Affairs Sciences, Nadia has a strong foundation in quality control, regulatory compliance, and project management. Her combined expertise allows her to effectively navigate complex regulatory requirements and help companies ensure the safety, quality, and effectiveness of their products. Outside of her professional life, Nadia maintains a balanced lifestyle, enjoying a consistent yoga practice that supports her overall well-being and personal growth.
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