Manager, Clinical Compliance

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! The role of the Manager, Clinical Compliance is to provide leadership with respect to Canadian specific clinical requirements, interpretation and application of Health Canada Regulatory Guidance and Policy as well overall clinical strategies for Canadian filings. Your Key Responsibilities: Your responsibilities include, but not limited to: Responsible for the preparation and/or review of Scientific Advice submitted to Health Canada. Responsible for organizing pre-submission meetings with Health Canada. Provide clinical guidance for licensing in collaboration with internal and external stakeholders. Manage, review and participate in the establishment of annual audit plans with Global Clinical Assurance. Manage auditors and oversee outsourcing, contracting, and collaboration with external specialists for the conduct of clinical and non-clinical studies. Ensure regulatory compliance and monitor key quality and performance metrics for patient support programs and research collaborations. Implement and maintain a practical quality management system, overseeing the execution of all components (SOPs, quality control, audits). What you’ll bring to the role : Essential Requirements: Minimum of master’s in Pharmacology, Biochemistry, Chemistry, or a Pharmacy diploma. Minimum of 5 years of experience in Clinical regulatory and/or Scientific Affairs in Canada. Minimum of 2 years in managing projects. At least 3-5 years of experience as a people manager. Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally. Desirable Requirements / Assets: Experience in business development and licensing management. Experience with SAP. Experience as a pharmacist. Experience in communicating with Health Canada. You’ll receive: A minimum of three weeks’ vacation. Paid time off in addition to your annual vacation and statutory holidays. Time back between Christmas and New Year’s Day with full pay. Group pension plan with substantial employer contributions. Generous and flexible group insurance coverage through our private plan. Employee and family assistance. Hybrid work formula offered. Telemedicine services. Parental leave – supplemental top-up payments up to 100% of base salary, regardless of gender or sexual orientation. Career enhancement and development, including learning, training and professional recognition opportunities. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100 countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! Inclusion at Sandoz : At Sandoz, we aim to create a safe and inclusive environment where everyone feels valued, respected, and heard. This is how we define an inclusive workplace. Part of living our inclusive culture includes meritocracy: creating an environment where individuals are recognized and rewarded based on their abilities and achievements. As an employer, we aim for fairness and non-discrimination.

Location: Longueuil, Quebec, CA

Posted Date: 7/3/2025