Associate Regulatory Program Director - Pharma Technical Regulatory

At Roche you can show up as yourself, embraced for the unique qualities you bring. 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.

The Position

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.

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, collaborative 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 115 328,00 and 151 368,00 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. 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.

Let’s build a healthier future, together.