Regulatory Program Manager

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

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 as a Regulatory Program Manager you will be part of the Pharma Technical Regulatory Submission Management Group. In this Regulatory Operations role, you will play a pivotal part in global planning, tracking, and monitoring of regulatory information crucial for compliance and successful submission execution.

The Opportunity:

1. You will manage regulatory information activities in coordination with the regulatory product portfolio team.
2. You will partner with various departments to ensure seamless submission processes.
3. You will lead all aspects of the editing and formatting of technical documents.
4. You will coordinate document flow within the management system and ensure version control throughout the submission process.
5. You will ensure timely delivery of content and maintain clear communication with technical subject-matter experts.

Who you are

1. You will bring a Bachelor's or higher degree in Biology, Chemistry, English, or a related field.
2. You will be proficient in document management best practices and comfortable with diverse digital tools.
3. You will be skilled at building productive relationships across departments and with external partners, thriving in a diverse team.
4. You will be an effective problem-solver with excellent interpersonal skills, able to prioritize multiple tasks.
5. You will bring experience in scientific editing with a solid understanding of standard style manuals (e.g., The Chicago Manual of Style) and scientific terminology.
6. Be committed to continuous improvement, always looking for ways to enhance processes, systems, tools and open to giving and receiving feedback.
7. Extensive experience with Veeva RIM (Regulatory Information Management) system is highly desirable.

Relocation benefits not eligible for this position

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.

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.