Regulatory Affairs Manager - Mississauga

Our client, an established and growing pharmaceutical manufacturer, is seeking a Regulatory Affairs Manager to lead its Health Canada submission strategy and regulatory operations. This is a senior, hands on leadership role for a regulatory professional who thinks strategically, executes with precision and has taken multiple submissions from compilation through to approval. You will own the regulatory lifecycle of a growing product portfolio, from filing strategy and dossier preparation to deficiency management, approval and post approval change control. You will lead and mentor a small regulatory team, manage external consultants and vendors, and act as the regulatory voice across Quality, Manufacturing, Clinical, Supply Chain, Marketing and Product Development. Deep Health Canada experience is essential. Experience with other regulated markets, including the FDA, EMA and Australia, is a strong asset. Responsibilities include but are not limited to: • Lead the preparation, filing and lifecycle management of Health Canada submissions, including ANDS, SANDS, DIN applications, labelling changes, post Notice of Compliance changes and administrative submissions. • Define filing strategy for each submission and guide it from compilation through deficiency management to approval. • Lead deficiency responses and agency interactions, delivering clear, well supported answers with successful outcomes. • Review Drug Master Files and Certificates of Suitability, identifying deficiencies that affect filing strategy and resolving them with manufacturers and vendors. • Conduct dossier gap assessments across Quality modules (Module 3), stability data, bioequivalence studies and DMF and CEP documentation. • Manage external consultants, CROs, manufacturers and regulatory vendors to timelines and quality standards. • Own post approval lifecycle management, handling changes strategically to support Supply Chain and Quality Assurance. • Prepare and publish electronic submissions in eCTD format using systems such as Docubridge or GlobalSubmit. • Partner cross functionally with Quality Assurance, Manufacturing, Clinical, Supply Chain, Marketing and Product Development to align regulatory strategy with business priorities. • Lead, coach and develop a team of regulatory professionals, including performance management and career development. • Advise senior leadership on regulatory strategy, risk and opportunity, not only submission execution. Qualifications • Eight or more years of pharmaceutical Regulatory Affairs experience, with a focus on Canada. Exposure to other regulated markets such as the FDA, EMA and Australia is a strong asset. • Five or more years of direct Health Canada submission experience across ANDS, SANDS, DIN applications, labelling changes, post NOC changes and administrative submissions. • A track record of leading multiple ANDS submissions end to end, and the ability to speak to filing strategy, deficiency management, approval outcomes and lessons learned. • Strong deficiency response experience, including leading agency interactions with demonstrated successful outcomes. • Proven expertise reviewing DMFs and CEPs and identifying issues that shape filing strategy. • Demonstrated capability in dossier gap assessment, including Module 3, stability data, bioequivalence studies and DMF and CEP documentation. • Experience directly managing two or more professionals, with coaching, performance management and career development responsibility. • Experience managing external consultants, CROs, manufacturers and regulatory vendors. • Working knowledge of eCTD publishing and electronic submission systems such as Docubridge or GlobalSubmit. • Experience with post approval lifecycle management in support of supply chain and quality objectives. • A strategic mindset with the ability to discuss regulatory strategy, not just submission execution.