Samar Darwish, M.Sc., MBA

Vice Chair

Reporting to the Medical Director, provide regulatory direction to the Canadian Human Pharma operating unit and the global corporation to ensure that strategic definition, management and implementation of regulatory policy, strategies/programs for human investigational and new product registrations are executed in line with local business, regional and global strategies as well as market access priorities and needs. · Active member of the Human Pharma Steering Committee. · Established, developed and maintained close professional relationships with relevant National Regulatory Authorities and other bodies/organizations/Industry associations/key stakeholders to facilitate and develop effective collaboration on all regulatory interactions, supporting the interests of Boehringer Ingelheim. · Led the development, facilitation and execution of comprehensive Canadian regulatory strategies (pre-launch to Loss of Exclusivity). · Provided senior management with critical risk assessments of the strategic alternatives for regulatory positioning; prioritized, planned, delegated and evaluated deliverables to established strategic goals. · Provided leadership, talent management, and strategic direction to the Regulatory Affairs team and ensured adequate staffing and resource planning by defining and obtaining overall financial and human resource needs to support the above activities in the most efficient and effective way possible. · Managed and maintained headcount and submission fees budgets.

Reporting to the Medical Director, led the Canadian and Caribbean Regulatory Affairs and PV team of 23, overseeing regulatory activities/registrations of Human Pharma prescription and Consumer Health Care (CHC) products in 18 English speaking Caribbean countries in addition to providing regulatory direction to the Canadian operating unit and the global corporation. - Active member of the Human Pharma Steering Committee. - Worked collaboratively with 3 cross-functional teams of up to 10 to support the product launch of 3 blockbuster status drugs, representing >$10M/month in revenue per drug. - Served as a member of the IMC, chaired a working group of 5 that re-defined the HC Annual Performance Report, producing format that addressed both HC and industry needs. - Defined and created internal process for generating local Risk Management Plans (RMPs) supplementing the Global RMPs that resulted in authoring 6 local RMPs. - Led the successful implementation of the swap of BI Canada’s CHC business portfolio with Sanofi in exchange for their Animal Health products as part of a global BI strategy to divest CHC products from their portfolio. Cross Functional Experience: - September 2017-February 2018: Participated in a job rotation in HealthCare Affairs as Director of National HealthCare Affairs, with national responsibility for a staff of 15 customer facing team members. Worked closely with the Executive Director, Patient Access, Health Economics/Pricing and HealthCare Affairs Solutions to plan and execute the 2018 Corporate Strategic Planning session. - April 2010-October 2010: Acting Director, Medical Affairs (Secondment): leading the Medical Affairs team until a new Director was hired. - 2009: Appointed Acting Medical Director, Medical Department to cover the 2009 Medical Director’s 3- month absence; successfully negotiated resources and headcount for the department with Global.

Reporting to the Medical Director led a Regulatory Affairs team of 15, ensuring budget tracking and expenditure transparency. - Acted as Deputy Director during absences; promoted to Director, Pharmacovigilance & Regulatory Affairs after 1 year.

Reporting to the Director, Regulatory Affairs, promoted to manage a portfolio of 10 products in development and marketed status. - Successfully handled complex projects such as registration strategies for 5 line extensions and 2 drug/device combination products through their lifecycle until Loss of Exclusivity. - Mentored junior staff and new hires; promoted to Senior Project Manager after 2 years and subsequently to Associate/Acting Director.

Reporting to the Manager, Regulatory Affairs, recruited to manage a portfolio of products in development and marketed status.

Contract position, Mat leave replacement Reporting to the Manager, Regulatory Affairs, hired to ensure life cycle maintenance and product compliance for vaccines.

Multi-Organ Transplant Unit Supported organ rejection and Type I Diabetes research project; published abstracts and presented at conferences. o S. EL-HAGE, J. Leushner, J. Dupre, M. Behme, E. Heinicke, J. MaCallum (1993): Predictive markers for Type I Diabetes: a comparison of ELISA’s for Glutamic Acid Decarboxylase. American Diabetes Association Workshop, Orlando, Florida. o S. EL-HAGE and J. Leushner (1992): Characterization of protein and peptide auto antigens in the determination of the pre-diabetic patient. CFBS, June 18-20, Victoria, B.C.

Maintained records for lab research and conducted research activities.

Ivey Scholar

Masters in Molecular Biology

Bachelor of Science