Senior Specialist, Regulatory CMC

Medexus Pharmaceuticals Inc. is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto‑immune disease, specialty oncology, allergy, and pediatric diseases. We provide market‑leading prescription and over‑the‑counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments:
Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners.

Reporting to the Senior Director, Regulatory Affairs & Pharmacovigilance, the Senior Specialist, Regulatory CMC manages Chemistry, Manufacturing and Controls (CMC) change controls and the resulting regulatory work for pharmaceutical products in Canada and the United States. The role assesses changes, determines the appropriate reporting pathway and implementation requirements, prepares post‑approval submissions and notifications, and coordinates documentation and follow‑up with internal teams and external partners.

Working across a diverse product portfolio and with internal and external partners, the role manages multiple concurrent CMC changes and regulatory activities with varying timelines, dependencies, and supply considerations. This dedicated capacity supports compliant product lifecycle management and timely execution across the portfolio.

• Manage the regulatory assessment and execution of CMC change controls for Canadian and U.S. products, from initial review through implementation and closure
• Evaluate manufacturing, analytical, supplier, site, packaging, formulation and process changes against approved dossiers and applicable requirements; document the reporting category, supporting data, approval or notification needs, and implementation timing
• Independently assess routine and moderately complex CMC changes and recommend regulatory pathways, escalating novel, high‑risk, or precedent‑setting matters to regulatory leadership
• Coordinate with Quality Assurance and technical teams to resolve information gaps, track dependencies and confirm that changes are implemented and documented in accordance with regulatory requirements
• Manage multiple concurrent CMC changes and related submission activities, prioritizing work based on regulatory requirements, implementation timelines, supply impact, and business risk

• Prepare, review and coordinate CMC submissions and maintenance activities arising from changes, including Canadian Level III notifications and relevant DEL or labeling updates, and U.S. Annual Reports and CBE-0/CBE-30 submissions, as applicable
• Review technical source documents and submission content for accuracy, consistency with approved dossiers and readiness for publishing and filing
• Track filing dates, health authority responses, regulatory commitments and implementation milestones; maintain complete and traceable submission records

• Work with internal Regulatory Affairs, Quality Assurance, Technical Operations, Supply Chain and labeling teams, as well as CDMOs and other external partners, to obtain required technical documentation, resolve information gaps, align filing and implementation plans, and support continuity of supply
• Coordinate with regulatory operations or publishing resources on eCTD preparation,…