Regulatory Program Manager - Pharma Technical Regulatory

Roche•Mississauga, ON

1d•$89,256 - $117,149•Hybrid

About The Position

At Roche, we foster a culture where individuals are embraced for their unique qualities, encouraging personal expression, open dialogue, and genuine connections. We value, accept, and respect everyone, enabling them to thrive personally and professionally. Our mission is to prevent, stop, and cure diseases and ensure universal access to healthcare for present and future generations. Join Roche, where every voice matters. As a Regulatory Program Manager, you will be instrumental in bringing innovative treatments to patients by shaping and executing global regulatory strategies. You will be part of a dynamic, collaborative global team, leading significant interactions with Health Authorities and industry experts to ensure timely approvals throughout our product lifecycles. This role offers a unique opportunity to influence the broader healthcare environment while promoting a supportive culture of continuous improvement and regulatory excellence.

Requirements

Bachelor’s degree in a life science discipline (a postgraduate degree is a plus).
Minimum of 3 years of industry experience in technical regulatory, manufacturing, or quality fields within the pharmaceutical or biotechnology sectors.
Deep technical understanding of drug development, biologics manufacturing, critical quality attributes, control systems, and commercial lifecycle management.
Experience in developing global regulatory strategies, conducting robust risk assessments, and successfully navigating interactions with international Health Authorities.
Outstanding communication and organizational skills, allowing you to synthesize complex issues, make confident decisions, and thrive in a fast-paced environment.
Agile, collaborative leader with a proven ability to build trusted, sustainable relationships across multidisciplinary internal departments and with external partners.

Nice To Haves

Biologics experience is highly desired.

Responsibilities

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 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.