Experience

Montreal Health Innovations Coordinating Center (MHICC)

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Executive Director

  • May 2022 - Present

  MHICC is a full service clinical academic research organization, providing services to the academic community and to the pharmaceutical, biotechnology and medical device industries, in the fields of cardiology, neurology, oncology, gastroenterology, endocrinology and pharmacogenomics. The MHICC’s flexible, dynamic and fully integrated range of services can handle Phase I to IV clinical research needs, with a network of collaborators at 4,500 clinical sites in 35 countries. It has specific expertise in precision medicine, high-quality low-cost clinical trials and the development of new applications for existing drugs. Show less



Christie Innomed

• Canada
• Hospitals and Health Care
• 100 - 200 Employee

• Director of Regulatory Affairs and Quality Assurance

  • Jan 2022 - Apr 2022

  Christie Innomed, Canada’s largest independent Healthcare company, develops, distributes, and supports innovative solutions to improve the performance of Healthcare Institutions in the area of Medical Imaging and Information Management. I managed all quality and regulatory activities for the organization. Christie Innomed, Canada’s largest independent Healthcare company, develops, distributes, and supports innovative solutions to improve the performance of Healthcare Institutions in the area of Medical Imaging and Information Management. I managed all quality and regulatory activities for the organization.



Pharmascience

• Canada
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Director, Innovative Product Development Strategy, Reporting to CEO

  • Nov 2016 - Dec 2021

  Pharmascience is a global pharmaceutical company with both generic and branded products, R&D, Manufacturing, and Commercial operations. As Head of Innovation, I was responsible for developing and implementing strategies to foster and accelerate innovative product development. Oversaw drug development, clinical and regulatory affairs.

• Sr Director, Global Regulatory Affairs, Reporting to CSO

  • 2014 - Nov 2016

  As Head of the Global Regulatory Affairs Department and member of the Senior Leadership Team, I oversaw regulatory processes and strategies for the company’s portfolio (over 450 products including Rx, OTC, NHP and medical devices). I was accountable to meet submission timelines for all product applications, generic and brands (including 1 Biosimilar), and for ensuring compliance worldwide (over 60 countries). Led a team of 60 regulatory personnel to work cross-functionally in a global set-up.

• Director, Regulatory International and Innovative, Reporting to CSO

  • 2013 - 2014

  Responsible for international regulatory strategy development, regulatory submissions, lifecycle management, interfacing with Health Authorities globally, resource management (24 employees) and financial management. Built the regulatory infrastructure to support the development and commercial activities for two new markets: Asia (Hub) and Saudi Arabia (TSO).

• Director, Clinical and Regulatory, Reporting to VP of Clinical/Innovative

  • Jun 2009 - Dec 2012

  Built a regulatory affairs team (10 employees) and developed processes to support the newly founded business for innovative branded products. Lead the bioequivalence group, from both a strategic and operational perspective, which resulted in a record number of biostudies conducted annually (59 vs 28) and savings of over $1.3M.



OVOS Natural Health Inc. (a wholly-owned subsidiary of BELLUS Health Inc.)

• Montreal, Canada Area

• Director, Global Regulatory Affairs, Reporting to CEO

  • Jan 2008 - May 2009

  OVOS is an international natural health company devoted to developing scientifically and clinically tested products for age-associated memory impairment conditions. Responsible for leading and directing the regulatory affairs function, from both a strategic and operational perspective. OVOS is an international natural health company devoted to developing scientifically and clinically tested products for age-associated memory impairment conditions. Responsible for leading and directing the regulatory affairs function, from both a strategic and operational perspective.



Canreg Inc

• Canada
• Hospitals and Health Care
• 1 - 100 Employee

• Associate Director, Regulatory, Reporting to VP of International

  • 2006 - 2008

  CanReg was Canada's largest regulatory consulting company with a team of >100 individuals located in Canada, the US and Europe covering registration activities across drugs, biotechnology products and medical devices in >60 countries. As the Head of the Quebec Business Unit, I was responsible to create a new successful local consultancy branch based in Montreal. My mandate was to build a team of local regulatory consultants, recruit new clients and develop strong relationship with existing clients. Show less

• Regulatory Affairs Manager, Reporting to VP of International

  • 2005 - 2006

  Worked directly with biotechnology/pharmaceutical senior management and technical experts providing consulting services including development strategies (clinical and regulatory), problem-solving and regulatory intelligence. Managed submissions and approval process for multiple key products in Canada, United States and European Union. Provided leadership, direction, and motivation to team members and coop students.

• Regulatory Affairs Project Leader, Reporting to Director of US Regulatory

  • 2004 - Dec 2004

• Regulatory Affairs Associate, Reporting to Director of US Regulatory

  • 2003 - 2004



Schering-Plough Healthcare Products, Inc.

• United States
• Hospitality
• 1 - 100 Employee

• Regulatory Affairs Associate & Consumer Relations Manager, Reporting to Director of Regulatory

  • 2002 - 2003

  Schering-Plough is a global, science-based healthcare company with leading prescription, consumer and animal health products. Responsible for all regulatory activities pertaining to OTC drugs and cosmetics. Provided supervision and leadership to Consumer Relation Representatives. Monitored and reviewed consumer complaints relating to quality complaints, medical information, adverse events, and reported serious cases to government regulatory agencies.

• Regulatory Affairs /QA Coordinator, Reporting to Director of Regulatory Affairs

  • Feb 2001 - Jan 2002



University Laval

• Quebec, Canada

• Research

  • Jan 1995 - May 1999

  Identified neuronal localization of several monoclonal antibodies detected by immunostaining procedures applied to brain tissue obtained from normal human individuals and patients with neurodegenerative disorders. This research program was conducted to better understand the phenomenon that may contribute to the development or propagation of pathological aspects found in neurodegenerative diseases including Alzheimer’s, Huntington’s and Parkinson’s. Identified neuronal localization of several monoclonal antibodies detected by immunostaining procedures applied to brain tissue obtained from normal human individuals and patients with neurodegenerative disorders. This research program was conducted to better understand the phenomenon that may contribute to the development or propagation of pathological aspects found in neurodegenerative diseases including Alzheimer’s, Huntington’s and Parkinson’s.