Supervised group of 3 associates/submissions of generic drugs to Health Canada for approval.

Responsible for preparing Finished Product section of draft BLA for influenza vaccine to be submitted to FDA. Responsible for Product Monograph updates for Canadian influenza vaccine, review of promotional materials. Interacted with Clinical, Quality Assurance, Quality Control, Marketing and Canadian and U.S. regulatory colleagues.

Head /Associate Director of regulatory affairs & QA programme in start-up biotech/pharma company. Products included protein for prostate cancer, antibody for cancer treatment, diagnostic kit for prostate cancer, topical cream for scar reduction/healing, antiviral HIV/AIDS protease inhibitor. Interacted with clinical groups, business development, license partners/regulatory authorities.