Regulatory Affairs Associate

4 weeks ago

Mississauga Ontario CW, Peel region, Canada F. Hoffmann-La Roche Gruppe Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Job Title: Regulatory Affairs Associate

Division: Medical Regulatory Affairs

Location: Mississauga Campus

Duration: Temporary Full Time - 12 Month Contract

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 role is an integral part of the Regulatory Affairs Chapter working strategically and collaboratively across local and global networks to file time-sensitive safety and chemistry and manufacturing (CMC) submissions to Health Canada. This role is also responsible for leading special projects aimed at enhancing processes, driving change management, and actively participating in regulatory consultations and modernization initiatives.

We are currently seeking a collaborative and motivated individual to join our team as a Regulatory Affairs Associate. In this role, you will be responsible for the strategic planning, and timely preparation and approval, of post-authorization changes (Supplemental New Drug Submissions, Notifiable Changes, Level III/IV changes), and support various components of New Drug Submission filings. Your responsibilities will also involve collaborating and actively participating with local and global cross-functional submission teams, and 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 systems used for regulatory filings and support 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 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 have a Pharmacy degree, or hold a Master's degree or 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.
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.

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