Job Description

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.
The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves. We innovate. Within the PDR Program Management Chapter, we are responsible for delivering global regulatory strategy and end to end execution of clinical projects in the Roche portfolio, in order to develop and maintain Roche product licenses to meet the needs of our patients. We deliver the regulatory components of clinical development and registration programs for products both pre- and post-licensing. We do this by developing innovative and effective global regulatory strategies, assessments and plans and support documentation in collaboration with regional regulatory affairs counterparts, cross functional product teams, corporate partners and global health authorities, based on current regulatory knowledge and expertise.
As an Associate Director - Regulatory Program Management Professional in the Program Management Chapter, you will lead and support global Health Authority interactions and procedures, represent regulatory affairs on cross-functional project teams and ensure the consistent and safe use of our medicines through high-quality labels. Additionally, you understand how data and information contribute to the quality of our submissions.
We are eager to welcome dynamic and curious individuals to our Global Regulatory Program Management organization at our Mississauga (Canada) Office.
The Opportunity:
Collaborate cross-functionally to develop and implement regulatory strategies and risk mitigations to facilitate the development, approval and life cycle management of Roche product licenses
Lead discussions and contribute to interpreting the needs of worldwide evolving pharmaceutical regulations
Drive gathering of regulatory intelligence necessary to generate, interpret and present insights that meets the needs of health authorities, patients, purchasers and prescribers for Roche's global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing
Actively manage the timely submission of applications to/interactions with health authorities for approval of clinical trials, new products and line extensions
Enable successful issue management
Who you are:
Degree in Life Sciences or equivalent with 5 - 7 years of relevant experience in the pharmaceutical/biotechnology industry, including independent project delivery and leadership of complex projects.
Experience in leading cross-functional teams and generating insights
Experience working with Health Authorities and knowledge of regional/global drug development processes, regulations, and guidelines (GxP, GCP, ICH), GVP and GCP principles including data integrity.
Candidates with strong medical device and/or safety experience preferred
Strong computer skills across G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
Strong interpersonal abilities, effective collaboration in cross-functional and matrix-based environments, and fluency in English (verbal and written).
Our team follows a hybrid work structure (majority of days on-site is required).
Relocation benefits are not available for this job posting.
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 is an Equal Opportunity Employer.

Skills Required