Mike Simukaitis

- Experienced Manager with a progressive career base and strong results recognized by stakeholders. - Strong longterm strategic outlook and broad working knowledge of the functional organization of the pharmaceutical industry and Health Canada. - 4-time recipient of prestigious President's Award for key Regulatory achievements by the respective team. Key Accomplishments: - Obtained priority review status for original NDS and subsequent new indication for a prostate cancer drug. - Obtained priority review status for 2 key vaccines, facilitating early market entry. - Successfully drove timely NDS approvals to meet stakeholder needs for market entry. - Led or co-led pre-NDS meetings to ensure Health Canada buy-in, facilitating timely registrations. - Resolved critical ethical and product issues of supply, specifications, labelling, promotion, lot release, and NOD issuance, enabling stakeholder needs to be met. - Proven management style of empowerment and delegated responsibility with accountability. Specialties: - Regulatory experience with Oncology, Biologics, vaccines, CNS, anti-infectives, Women's Health, cardiovascular (TPD, BGTD at Health Canada). - Experienced in cross-functional team activity to ensure buy-in on decisions.