We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

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.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.Capability to negotiate and maintain channels of communication with Health Canada and in building effective regulatory agency relationships.Food and Drug Act, Health Canada Policies, guidance documents etc.) 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.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.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 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. 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.

Travailler de concert avec les Opérations réglementaires pour assurer la préparation de soumissions de haute qualité et ainsi obtenir une approbation réglementaire en temps opportun pour les produits du champ thérapeutique assigné. Assurer un suivi proactif et veiller à la conformité avec les exigences de Santé Canada, les politiques d’entreprise et les processus internes. Excellentes aptitudes en communication orale et écrite, en anglais et en français.

Études/Expérience/Licences/Certifications : Baccalauréat (B.Sc.). Minimum de 7 années d’expérience en réglementation ou couplées à une expérience au sein de l’industrie pharmaceutique, dans un domaine scientifique pertinent.

Déplacements: Le poste exige un minimum de déplacements Le français est la langue de travail au Québec. Toutefois, ce poste nécessite une maîtrise de l’anglais, tant à l’oral qu’à l’écrit,



en raison d’interactions régulières avec des partenaires, équipes et parties prenantes situés à l’extérieur du Québec.Montreal - QC - CA: $104,300 - $126,381 La plage de rémunération de départ pour ce poste est indiquée ci-dessus sur la base d’un emploi à temps plein (FTE). Montreal - QC - CA: $104,300 - $126,381 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis.

The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Where you work matters – because collaboration, innovation and patient impact happen in many settings.

Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. Learn more at People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: If you live in or expect to work from Washington State if hired for this position, please visit this page for significant information about the Washington Fair Chance Act.Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] check your application status, please login to your Candidate Home Account.

📌 Chef(Fe), Réglementation/ Manager, Regulatory Affairs (Winnipeg)
🏢 0035 BMS Canada
📍 Winnipeg