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Regulatory Affairs Associate

1 day ago

Mississauga, Ontario, Canada Roche Full time

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 Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. Our strategic focus is on building, submitting, and obtaining authorizations for Clinical Trial Applications, New Drug Submissions, and New Indications. Additionally, we collaborate with external partners to shape regulatory policies that eliminate barriers, enabling faster access to medications and therapies for patients.

The Regulatory Affairs Associate is a critical and collaborative role within the Regulatory Affairs Chapter. This position is responsible for the strategic planning, timely preparation, and successful approval of post-authorization changes, including Supplemental New Drug Submissions, Notifiable Changes, and Level III/IV changes, as well as supporting various components of New Drug Submission filings to Health Canada. The Associate will also work strategically across local and global networks to file time-sensitive safety and Chemistry and Manufacturing (CMC) submissions. This role involves actively collaborating with local and global cross-functional submission teams.

Key responsibilities also include:

  • Leading special projects to enhance processes and drive change management.
  • Actively participating in regulatory consultations and modernization initiatives.
  • Contributing to the development and maintenance of local Standard Operating Procedures (SOPs), process maps, and operating guides aligned with Canadian regulatory requirements.
  • Staying updated on relevant systems used for regulatory filings.
  • Supporting cross-functional processes.

The Opportunity

  • You are accountable for planning, strategizing, preparing, and managing timely approvals as necessary for safety-related submissions, such as safety label updates in line with CDS, DHCPs/DILs, Risk Management Plan preparation and maintenance, PBRER submissions, and reporting of foreign actions.

  • You are accountable for planning, strategizing, preparing, and managing timely approvals as necessary for chemistry and manufacturing (CMC) submissions impacting the Certified Product Information Document (CPID), QOS, and Module 3, lead Yearly Biologics Product Report (YBPR) preparation and filing, and conduct environmental monitoring.

  • You lead or support preparation and execution of pre-submission meetings with Health Canada as necessary.

  • You review artwork for product packaging including inner and outer labels, and the package insert for compliance with Canadian requirements
  • You support promotional material reviews
  • You maintain up-to-date knowledge of, and work within, internal regulatory systems and platforms used for compliance tracking to efficiently execute day-to-day activities and support cross-functional processes.
  • You actively engage with the Regulatory Affairs Associate team and the Regulatory Affairs chapter, and are comfortable speaking up, and challenging when necessary.
  • You work collaboratively, sharing expertise within the Regulatory Affairs chapter, and across the organization, to eliminate silos and duplication, ensuring efficient use of skills.
  • You lead and manage implementation of improvements to regulatory processes for more efficient and successful regulatory submissions.

Who you are:

  • You hold a Bachelor's Degree in a science-related field
  • You possess a minimum of 3-5 years work experience in Regulatory Affairs
  • You have experience in the pharmaceutical/biotech industry in Regulatory Affairs
  • 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, with experience using a Regulatory Information Management System (eg. Veeva)
  • Proficiency with VEEVA RIM is an asset

Preferred:

  • You have a Pharmacy degree, or hold a Master's degree or Graduate certificate in Regulatory Affairs
  • 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 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 is an Equal Opportunity Employer.