Regulatory Affairs Specialist
CurrentAchievement: Successfully co-implement the Electronic Common Technical Document (eCTD) submission process, ensuring compliance with Health Canada's mandatory regulations.Role: Oversee all regulatory documentation for private labels, medical devices, wholesale business, and vendors, ensuring compliance with federal and provincial agencies.-Maintain Licenses: Handle renewals and amendments for various drug and medical licenses.-Vendor GMP Evidence: Ensure GMP evidence for foreign buildings in non-MRA countries.-Regulatory Documentation: Manage and file documentation for both marketed and new drug products.-Publish eCTD sequences for various drug submission activities.-Foster strong relationships (suppliers/Health Authorities) to obtain necessary documents and information.-Review labels to align with Health Canada’s guidelines.-Respond promptly to requests from health authorities.-Manage change requests for all regulatory activities as per internal SOPs.-Ensure effective filings and timely notifications for provincial reimbursement programs.-Continuously monitor Health Canada’s guidelines for updates affecting the business or products.
