Regulatory Program Management Specialist - Program Management
Together, we embrace individuality and share a passion for exceptional care. 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 a member of this 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 two dynamic and curious individuals to our Regulatory Program Management organization.
The Opportunity:
- Contribute to the development and implementation of regulatory strategies and risk mitigations to facilitate the development, approval and life cycle management of Roche product licenses
- Participate in discussions and contribute to interpreting the needs of worldwide evolving pharmaceutical regulations
- Support 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
- Coordinate the timely submission of applications to/interactions with health authorities for approval of clinical trials, new products and line extensions
- Coordinate successful issue management
Who you are:
- Degree in Life Sciences or equivalent with 3 years of relevant experience in the pharmaceutical/biotechnology industry, including independent project delivery and leadership.
- Strong digital literacy across G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
- Working knowledge of regional/global drug development processes, regulations, and guidelines (GxP, GCP, ICH) and an understanding of GVP and GCP principles including data integrity.
- Strong interpersonal abilities, effective collaboration in cross-functional and matrix-based environments, and fluency in English (verbal and written).
- Ability to work under minimal supervision, detail-oriented with excellent administrative and project planning skills, curiosity, adaptability to change, and proactive learning.
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
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.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely.If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.