Known for her contributions to the growth and success of a variety of pharmaceutical organizations, Irma Monaco has acquired nearly two decades of experience in the areas of submissions management and medical services. Her technical and analytical expertise covers a wide spectrum of pharmaceuticals, biologics, devices and over-the-counter products. In addition, she has experience ensuring that chemistry data, including submission data generated by the laboratory and process validation, complies with standard operating procedures and good manufacturing practice. Other specialties include Canadian regulatory strategy, medical affairs, pharmaceutical vigilance, and researching new European and Canadian guidelines.
Ms. Monaco is currently using her extensive background as the quality operations manager of EMD Serono, Inc., which is a biopharmaceutical division of Merck KGaA, a German multinational chemical, pharmaceutical, and life sciences company. The branch offers specialty care by “integrating cutting-edge science with industry-leading patient support.” In her position, Ms. Monaco is responsible for overseeing quality assurance and compliance for Canada. She attributes her success to her passion, patience and ability to connect with others, as well as mentors like Anne Tomalin.
Initially, Ms. Monaco became involved in her profession after graduation, when she interviewed with a firm that was being purchased by a larger company whose regulatory team was leaving. The head of regulatory services invited her to join her in a consulting role, where Ms. Monaco helped build a team from five to 100 people. She is quite proud of her role in the growth of the companies she has served, such as Methapharm Inc., CanReg Inc., and Fila.
To prepare for her career, Ms. Monaco earned a Bachelor of Science in mathematics from McMaster University in 1993 and became a certified pharmacy technician at Niagara College in 1995. She also maintained affiliation with prominent professional organizations like CAPRA, DIA, and RAPS.
Looking to the future, Ms. Monaco sees herself working with the key stakeholders in developing robust strategies to reduce the time it takes for a drug to reach the market, and hence, contributing to patient safety and the company’s success. Furthermore, she plans on assisting up-and-coming regulatory professionals in developing the correct approach to building relationships, thus maximizing the cost-effective use of company resources and coordinating scientific endeavors with regulatory demands throughout the life cycle of the product. If she could offer them some advice, it would be to persevere in the pursuit of goals and dreams.
