Driven healthcare professional with 5 years of combined experience in regulatory writing / reviewing and quality compliance in clinical research and pharmaceutical industry, currently seeking regulatory affairs / reviewing and medical / technical writing opportunities.
Certificate in Pharmaceutical Regulatory Affairs & Quality Operations Program from Seneca College.
In-depth knowledge in clinical trial development, regulatory CMC, FDA and Health Canada regulatory submissions (CTA/IND, NDA/NDS, ANDA/ANDS, DINA, DEL, Clarifax etc.), Food and Drug / Medical Device Regulations, and industrial guidelines (GCP, cGMP, GLP, GDP, ICH, ISO etc.). • Skilled in project management and literature / document review. Adept in problem-solving, multitasking and managing priorities. Fast learner with excellent verbal and written communication skills.
Experience
Driven healthcare professional with 5 years of combined experience in regulatory writing / reviewing and quality compliance in clinical research and pharmaceutical industry, currently seeking regulatory affairs / reviewing and medical / technical writing opportunities.
Certificate in Pharmaceutical Regulatory Affairs & Quality Operations Program from Seneca College.
In-depth knowledge in clinical trial development, regulatory CMC, FDA and Health Canada regulatory submissions (CTA/IND, NDA/NDS, ANDA/ANDS, DINA, DEL, Clarifax etc.), Food and Drug / Medical Device Regulations, and industrial guidelines (GCP, cGMP, GLP, GDP, ICH, ISO etc.). • Skilled in project management and literature / document review. Adept in problem-solving, multitasking and managing priorities. Fast learner with excellent verbal and written communication skills.
