Roberto Cunha

Regulatory Affairs Associate @SteriMax Inc.

Toronto, ON, CA

Responsible for the preparation and submission of Abbreviated New Drug Submissions (ANDS) and post-approval supplements to Health Canada for sterile injectables, complex generics, and biosimilars.• Coordinated dossier preparation and ensured compliance with Health Canada guidelines, including the preparation of product monographs, labelling activities, and eCTD publishing.• Led cross-functional strategy by liaising with QA, QC, R&D, and external partners to collect documentation, resolve deficiencies, and ensure alignment with project timelines.• Assessed change controls and provided regulatory strategies to support manufacturing site changes, stability updates, and compliance with Health Canada expectations.• Built strong internal and external relationships and championed process improvements within the Regulatory Affairs team, ensuring streamlined submission practices.• Supported Health Canada review process by drafting responses to Clarifaxes and Information Requests, coordinating data collection with stakeholders.• Contributed to the maintenance of regulatory databases and supported regulatory intelligence monitoring to anticipate Health Canada requirements.

UNIFENAS - Universidade Prof. Edson Antônio Velano

Bachelor's degree, Pharmacy and Biochemistry

Pós Graduação - Faculdades Oswaldo Cruz

Specialist, Regulatory Affairs