Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.La positionAs an Associate Regulatory Program Director, you will play a crucial role in bringing innovative treatments to patients by shaping and executing global regulatory strategies. You will join a dynamic, collaborative global team, leading impactful interactions with Health Authorities and industry experts to ensure timely approvals across our product lifecycles. This unique opportunity allows you to influence the broader healthcare environment while fostering a supportive culture of continuous improvement and regulatory excellence.The Opportunity:Drive the submission of high‑quality CMC regulatory documents to global health authorities, ensuring strict compliance with current Good Manufacturing Practices (cGMP) and international standards.Lead strategic informational and pre‑submission meetings with global Health Authorities and partners to facilitate optimal regulatory pathways and accelerate patient access.Partner with diverse, cross‑functional stakeholders to guide both synthetic and biologic products across their lifecycle, ensuring the accuracy of data in regulatory information management systems.Ensure that cross‑functional team deliverables are completed thoroughly, compliantly, and in a high‑quality,



timely manner to support the successful approval of Roche products.Contribute to regulatory excellence by identifying growth opportunities, mitigating risks, and proactively optimizing departmental business processes.Manage and deliver timely, strategic responses to questions received from major global regulators to maintain our right to operate.Who You Are:You hold a Bachelor’s degree in a life science discipline (a postgraduate degree is a plus) and bring a minimum of 5 years of industry experience in technical regulatory, manufacturing, or quality fields within the pharmaceutical or biotechnology sectors (biologics experience is highly desired).You have a deep technical understanding of drug development, biologics manufacturing, critical quality attributes, control systems, and commercial lifecycle management.You are experienced in developing global regulatory strategies, conducting robust risk assessments, and successfully navigating interactions with international Health Authorities.You possess outstanding communication and organizational skills, allowing you to synthesize complex issues, make confident decisions, and thrive in a fast‑paced environment.You are an agile, team-oriented leader with a proven ability to build trusted, sustainable relationships across multidisciplinary internal departments and with external partners.Additional Information:Location: Mississauga site, ON.Full time (35 hours per week)Hybrid, majority of days in the office.This position is not eligible for relocation support.The expected salary range for this position based on the primary location of Mississauga is 115328,00 and 151368,00 of hiring range. Actual pay will be determined based on experience, qualifications, and other job‑related factors as determined by the company.Roche est un employeur offrant l'équité en matière d'emploi.#J-18808-Ljbffr

📌 Associate Regulatory Program Director - Pharma Technical Regulatory - C$115,328 - C$151,368 A Year (Winnipeg)
🏢 Roche
📍 Winnipeg