Regulatory Clinical Trials Associate

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

Job title: Regulatory Clinical Trials Associate

Duration: 1 year contract

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.

We are currently seeking a collaborative and motivated individual to join our team as a Regulatory Clinical Trials this role you will be responsible for Clinical Trial Submissions including the planning strategy and timely
preparation and approval of Clinical Trial Applications (CTAs) and Medical Device Investigational Testing Authorizations (ITAs) to Health Canada. Your responsibilities will also involve actively participating in cross-functional meetings for study
submissions collaborating closely with local and global stakeholders contributing to the development and maintenance of local Standard Operating Procedures (SOPs) process maps and operating guides aligned with Canadian regulatory
requirements. Additionally you will stay updated on relevant regulatory systems used for CTAs/ITAs and support cross-functional processes.

The Opportunity:

• You are accountable for planning strategizing and preparing timely Clinical Trial

• Application (CTA) and Medical Device Investigational Testing Authorization (ITA)

• submissions to Health Canada including all types of submissions throughout the process.

• You are supporting preparation and execution of pre-submission meetings with Health Canada as necessary.

• You are responsible for preparing submissions and obtaining Health Canada authorizations for Dear Investigator Letters (DILs) and other urgent safety notifications pertaining to CTAs.

• You maintain up-to-date knowledge of and work within internal regulatory systems and platforms used CTA/ITA compliance tracking to efficiently execute day-to-day activities and support cross-functional processes.

• You are actively engaging with the CTA team and the Regulatory Affairs chapter comfortable speaking up and challenging when necessary.

• You are working collaboratively sharing expertise within the Regulatory Affairs chapter and across the organization to eliminate silos and duplication ensuring efficient use of skills.

• You are leading and managing implementation of improvements to regulatory processes for more efficient and successful clinical trial submissions.

Who you are:

• You hold a Bachelors Degree in a science-related field

• You possess a minimum of 1 year work experience in Regulatory Affairs

• You have experience in the pharmaceutical/biotech industry in Regulatory Affairs or Quality Department

• You have in-depth knowledge of Health Canada regulations and guidelines.

• Additionally knowledge of the EU and FDA regulations and guidelines are an asset to understand where the Canadian regulations align or contrast.

• You have the necessary knowledge of Microsoft Office and Google Suite

Preferred:

• You hold a Graduate certificate in Regulatory Affairs

• You demonstrate strong communication and problem-solving skills

• You have experience in process management planning and strong ability to meet

• tight deadlines

• You demonstrate the ability to collaborate and work as a team

• You demonstrate an enterprise mindset and the ability to work effectively across

• cross-functional areas in a fast-paced environment.

Relocation benefits are not available for this posting

We use artificial intelligence to screen assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

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 life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.