Providing Quality and Regulatory services for the Drug Pharmaceutical, Natural Health Product, Medical Device and
Cannabis industries including: Supporting regulatory licensing submissions, SOP writing and reviews, gap analysis, customer complaints investigations, product labelling reviews, auditing, security clearance applications, quality management systems, compliance training (GMP, GDP, NHP, Medical Device);

Managed the day-to-day activities of a team of quality and regulatory consultants by providing technical support
and management for projects including and not limited to Cannabis Licence Holder applications to Health Canada as
per the Cannabis Regulations, Gap Analysis, Transition, Amendment, and SOP writing projects.

Managed the day-to-day activities of the quality department by providing technical support to the quality team and
management for drug products (including sterile injectables and controlled substances) and natural health product ; Provided leadership role in handling the Quality systems; deviation, change controls, product releases, and customer complaints including pharmacovigilance (PV);

Prepared and coordinated the submission of license applications, amendments, site license renewals and all quality regulatory submissions for drug products, medical devices and natural health products.; Prepared and/or reviewed responses to deficiency letters; Acted as the primary contact for Health Canada for all matters

Executed aspects of quality compliance such as batch release and complaints investigation for assigned nonregulated and regulated product brands; Managed product quality and compliance for assigned GSK Sites that supply the Canadian Market ;Managed product release, approved deviations and change controls; measured
complaints, deviations, rejections, and key process parameters ;Supported corporate (MIA) and regulatory inspections (Health Canada);

Generated documentation forms while adhering to existing protocol and internal Anapharm SOPs/procedures for
bioequivalence, phase 1, and phase 2 clinical trials in various therapeutic areas including Diabetes, Oral Contraceptives, Hypertension, Blood Clot Formation, Hepatitis C, Epilepsy, and Respiratory and Skin Infections; Assisted in the development of the CPA role at Anapharm; Provided training to new team members and cross-training to other member of Anapharm including Clinical Team