Job DescriptionSenior Specialist of Regulatory Affairs and Quality Assurance at Ferring Canada. The role supports regulatory and quality activities for the company’s portfolio, ensuring timely approvals and ongoing compliance with Health Canada requirements, cGMP standards, and Ferring quality policies. The incumbent also mentors junior team members.ResponsibilitiesManage and support regulatory submissions (product registrations, amendments, supplements, and periodic reports).Provide regulatory guidance and strategic input to cross‑functional teams throughout the product lifecycle.Act as regulatory liaison with health authorities, addressing inquiries and facilitating approvals.Coordinate, compile, review, and maintain high‑quality regulatory documentation in compliance with internal and regulatory standards.Support regulatory strategy development, risk management, and implementation planning.Identify and act on opportunities to maximize the potential of the product portfolio.Ensure pre‑clinical and clinical trial documentation aligns with regulatory requirements.Provide regulatory input and ensure requirements are met for CMC submissions.Support post‑approval regulatory maintenance, including labeling updates and manufacturing changes.Help with DEL maintenance, SOPs, change controls, CAPAs, deviations, and other quality responsibilities.Coach and review the work of junior regulatory professionals as appropriate.QualificationsBachelor’s degree in Life Sciences, Pharmacy, Chemistry,



or a related scientific discipline.5+ years of progressive regulatory affairs experience within pharmaceuticals or biotechnology industries.Proven experience working with Health Canada and preparing Canadian regulatory submissions.Robust understanding of regulatory strategy, process, and change control.Experience in document lifecycle management and continuous monitoring activities.Understanding and capability to support quality functions.Ability to manage multiple projects independently with limited supervision.Strong analytical, problem‑solving, and communication skills.Proven ability to collaborate effectively across functions and build cooperative relationships within the company and with Health Canada.Proactive individual with a high work ethic.Excellent communication skills in English, written and verbal.Detail‑oriented, organized, and able to manage multiple priorities in a fast‑paced environment.BenefitsSalary range: $80,000 – $119,000 CAD annually, supplemented by a comprehensive benefits package.Inclusive support package “Building Families at Ferring” providing equal and accessible policies for employees wishing to start their family journey.Parental leave for both birthing and non‑birthing parents.Extended support on family building journey.LocationFerring CanadaWe strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.#J-18808-Ljbffr

📌 Regulatory Affairs & Quality Senior Specialist - C$80,000 - C$119,000 A Year (Toronto)
🏢 Ferring Canada
📍 Toronto