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. Its 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.

Thats 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 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 postlicensing. 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 Regulatory Program Management Specialist in the Program Management Chapter you will lead and support global Health Authority interactions and procedures represent regulatory affairs on crossfunctional project teams and ensure the consistent and safe use of our medicines through highquality 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 Welwyn United Kingdom or Mississauga Canada Offices.

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 Roches global Pharma Medicines Division which includes all therapeutic areas and all phases of product development from early development to postmarketing

• 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 1 3 years of relevant experience in the pharmaceutical/biotechnology industry including independent project delivery and leadership.

• Strong computer skills 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 crossfunctional and matrixbased environments and fluency in English (verbal and written).

• Ability to work under minimal supervision detailoriented with excellent administrative and project planning skills curiosity adaptability to change and proactive learning.

Our team follows a hybrid work structure (majority of days onsite is required).

Relocation benefits are not available for this job posting.

Who we are

A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.

Lets 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 Roches truly innovative culture.