Hajra S.

Summary • A dedicated, flexible professional with excellent organizational and problem‐solving skills supported by over 7 years of regulatory law ( cosmetics, medical devices, NHP) clinical research experience. • Provided support on all aspects of the Quality Management System including Regulatory Inspection, Corporate and Self‐Inspections, Recall Management, Contractor Compliance, Product Release, Stability Management, Change Control, Deviations, CAPA and GMP training. • Expertise in Good Manufacturing Practices (GMPs), Good Pharmacovigilance Practices (GVP), Current GMP for Canadian drugs and Natural Health Products, cosmetic regulations (Health Canada &FDA) and Good Clinical Practice (GCP)for pharmaceuticals. Applied a risk‐based approach to implementing regulations for various pharmaceuticals, cosmetics, Medical device and Natural Health Product companies, providing thoughtful justification for recommendations/decisions. • Knowledgeable about Health Canada practices and regulations for medical devices, NHPs, DINs, OTC drugs and cosmetics. Attentive and demonstrated success in handling domestic and international regulatory needs for diverse regulated product launches. Provided regulatory advice and risk assessment for business development. Adept at managing regulatory documents from start to finish, including assessing audits, evaluating technical data and checking information accuracy. Have successfully managed and obtained MDEL, Site Licenses, DEL and ISO quality management systems approvals for many companies. • Expertise in Completing the source documents, case report forms, and data queries in a timely manner, accurately, and completely for clinical trial. • A strong understanding of Cosmetic Regulations, Hot-listed/Restricted ingredients, Cosmetic Notifications, Label review, Quality Management, Clinical trials, regulatory work and an ability to implement challenging goals, objectives, and practices. • Worked successfully in a team‐based environment, as well as independently. Strong people management skills and leadership skills including coaching, mentoring and employee development. Efficiently prioritized and juggled many different projects and tasks by delegating to associates. Study: Bachelor of Science with specialization in Chemistry. Master of Drug Development which covers Clinical trials, BA/BE trials, Pharmacovigilance activities, Pharmaceutical regulated work for NHP, Cosmetics and Drug products. Base on education and training able to write regulated document such as SOP, regulated reports, label review, formulation compliance, cosmetics notification. Also able to manage clinical studies based on my experience.