Associate Regulatory Program Director - Pharma Technical Regulatory

Roche • Mississauga, ON

1d • $115,328 - $151,368 • Hybrid

About The Position

At Roche, we foster a culture where you can be yourself and are embraced for your unique qualities. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop, and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. As 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.

Requirements

• Bachelor’s degree in a life science discipline (a postgraduate degree is a plus).
• Minimum of 5 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 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.

Benefits

• A healthier future drives us to innovate.
• We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
• We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all.
• We are proud of who we are, what we do, and how we do it.
• We are many, working as one across functions, across companies, and across the world.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level