Chef(fe), Réglementation/ Manager, Regulatory Affairs

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Key Responsibilities:

• Represents Canada on the Global Regulatory Teams for assigned products, ensuring needs/requirements for registration in Canada are reflected in Global Regulatory Plans.
• Collaborates with local and global cross-functional teams to develop regulatory strategies/solutions and leads in the planning, execution and assessment.
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to local and global stakeholders.
• Manages the preparation, filing, interactions/negotiations with Health Canada during the review process to ensure optimal response strategies/outcomes for timely approvals.
• Provides critical review of documents (SOPs, protocols, and reports) related to clinical, drug safety, nonclinical or manufacturing, as necessary.
• In conjunction with Manager/RA Lead, plans and coordinates submission meetings with Health Canada (HC) for new products/line extensions, as necessary.
• Responsibilities include preparation and finalization of the briefing book materials and meeting minutes to HC.
• Works in partnership with Regulatory Operations to ensure preparation of high quality submissions to secure timely regulatory approval for products in assigned therapeutic area.
• Proactively monitors and ensures compliance with Health Canada (HC) requirements, corporate policies and internal processes.
• Communicates new or revised regulatory requirements to contributors, especially GRTs, Lifecycle Management Teams (LCMTs) and the Canadian Brand team.
• Reviews all promotional material for assigned products and ensures compliance of all facets of company business, HC regulations/guidelines, and PAAB guidances.

Specific Knowledge, Skills, Abilities:

• Capability to negotiate and maintain channels of communication with Health Canada and in building effective regulatory agency relationships.
• Excellent, up-to-date knowledge of all industry rules and regulations (e.g. Food and Drug Act, Health Canada Policies, guidance documents etc.) and all aspects of drug development processes and internal company procedures.
• Excellent knowledge, comprehension and application of (i) scientific principles of chemistry, toxicology, pharmacology, and statistics; (ii) drug development process, both nonclinical and clinical as well as (iii) medical principles and practices associated with Therapeutic Area of key assigned products.
• Good business knowledge.
• Excellent Computer Skills.
• Excellent English and French written and oral skills.

Education/Experience/ Licenses/Certifications:

• Bachelor’s degree (B.Sc.).
• A Master’s degree (M.Sc.) is an asset.
• Minimum of 7 years in regulatory affairs or combined with a pharmaceutical industry experience in a relevant scientific field.

Travel: Minimal travel required.

French Version

Assumer la responsabilité de l’homologation des nouveaux produits/des élargissements de gamme/des allégations. Appuyer les activités commerciales et assurer le respect de la réglementation; fournir aux équipes de développement des produits les exigences réglementaires canadiennes à cet égard. Responsabilités liées au poste Représenter le Canada au sein des équipes de la Réglementation à l’échelle mondiale pour les produits assignés; s’assurer que le plan de réglementation international respecte les exigences et les besoins canadiens en matière d’homologation. Collaborer avec des équipes interfonctionnelles locales et internationales dans le but d’élaborer des stratégies et des solutions réglementaires, puis en diriger la planification, l’exécution et l’évaluation. Déterminer les mesures d’atténuation et les risques potentiels associés aux stratégies réglementaires et les communiquer aux intervenants locaux et internationaux. Gérer la préparation, la soumission ainsi que les interactions et négociations avec Santé Canada durant le processus d’examen afin de s’assurer que les stratégies de réponse et les résultats sont optimaux et obtenus en temps opportun. Effectuer un examen critique des documents (les MON, les protocoles et les rapports) relatifs aux aspects cliniques et précliniques, à l’innocuité des médicaments ou à la fabrication, au besoin. En collaboration avec le gestionnaire ou le responsable de la Régleme