Toronto, Ontario, Canada
Pharmacist with a Post-Graduate degree in Regulatory Affairs and over 6 years of extensive experience in the pharmaceutical and life science industries. Acknowledged as a dynamic, highly motivated, results-driven professional with a proven track record of successfully navigating complex regulatory landscapes. Strong problem-solving skills and adaptability to new challenges.
• 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.
• Regulatory activities focused on the UK market in a post-Brexit projects. • Preparation and submission of regulatory applications on the MHRA portal. • Oversight of UK Marketing Authorizations (MAs) including safety and quality variations, renewals, PSURs, launches, withdrawals, and responses to RFI. • Management of eMC actions, encompassing PILs, SmPCs, DHPC Letters, and aRMMs. • Collaboration with cross-functional teams in Europe and India.
• Preparation and submission of regulatory applications, including responses to requests for further information from European agencies. • Effective communication with EU regulatory authorities. • Post-approval activities, MA maintenance, renewal applications, and launch coordination. • Maintenance of regulatory databases and interfaces with stakeholders.
• Proficiently handled post-registration processes with a focus on oncological and respiratory products. • Conducted risk assessments for proposed changes, GAP analysis, and product remediation. • Oversaw the review of medicinal leaflets, packaging materials, and promotional materials. • Managed submissions for Good Manufacturing Practice Certifications and ensured regulatory compliance. • Stayed up-to-date with evolving regulations and liaised with internal stakeholders: Head office, Latin American Affiliates, Marketing, Sales, Financial, Quality, Legal, COMEX, R&D, Pharmacovigilance, and Supply chain
• Specialized in regulatory processes related to active pharmaceutical ingredients, food additives, medical devices, and sanitizing products. • Facilitated market access for new food additives, pharmaceutical ingredients, excipients, and cosmetic ingredients. • Provided support for COMEX operations. • Led GAP analysis, post-market surveillance, and regulatory intelligence efforts.
• Managed regulatory processes for generics, biological products and RLD medicines. • Supported product registrations, renewals, and variations. • Evaluated promotional materials, leaflets, and labels for compliance.
• Specialized in medical devices, including Class III and IV. • Contributed to new product projects, licensing, audits, inspections, and certifications. • Developed procedures and conducted internal training. • Supported FDA registrations for medical devices.