Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 

That’s what makes us Roche.

In this individual contributor role in Pharma Technical Regulatory (PTR), focusing on broadening regulatory knowledge and aligning deliverables with the organization's North Star. You are encouraged to innovate, collaborate, and create impactful outcomes for patients, stakeholders, and the company. You will contribute to initiatives that shape technical business and healthcare environments

The Opportunity:

You will be responsible for global planning, tracking, and monitoring of regulatory information to ensure compliance and support submission execution.

You will develop and implement strategies for configuring submission data in regulatory information management systems, and manage regulatory information activities with the regulatory product portfolio team.

You will partner with various departments to align on a single regulatory data strategy, ensuring data monitoring, evaluation, and flow within systems.

You will edit and format technical documents, coordinate document flow and version control, plan and track submission generation activities, and manage regulatory data across multiple regions.

You will conduct in-depth analysis of reporting/metrics to transform regulatory information into actionable insights for regulatory and business decisions.

You will act as a Business Process Owner/Subject Matter Expert, develop process documentation, deliver training, and mentor others within and outside the group.

You will be required to Partner with Health Authorities and industry associations to ensure data compliance, influence new regulations, and uphold data governance standards. Analyze the impact of process changes on data integrity and resolve issues with stakeholders.

Who you are 

You have a BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a related field. 

You will have in-depth knowledge of Roche and regulatory guidelines,  procedures and best practices. You will develop and maintain global policies and/or Business Processes (BPs) where regulatory records  information management is impacted. 

You will perform system searches, prepare and analyze complex reports and oversee assembly of  documentation to support Stakeholders. 

Stays abreast of internal and external developments and understands required laws, regulations and  guidelines governing the development, licensure and marketing of drugs and biologics. Drive internal  and external awareness of the regulations. 

Demonstrates a continuous improvement mindset by: 

Identifying and recommending opportunities to streamline or improve processes, systems, and tools. 

Actively seeking feedback on self and providing feedback on others

Relocation benefits not eligible for this position 

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.