2025 Summer Intern - PTR Regulatory Affairs Intern (CMC)
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.
Pharma Technical Regulatory (PTR) provides world-class technical regulatory strategy and support for clinical trial applications, market applications, and post-approval change submissions globally.
The Opportunity:
In this role you are contributing to the preparation and filing of the CMC (chemistry manufacturing & controls) component of regulatory submissions to meet global filing data and timeline requirements, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups.The focus of this role is on providing support to global regulatory teams focused on CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle activities including dossier preparation.
- Responsible for generation and submissions of high quality CMC regulatory documents to global health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
- Help ensure cross-functional coordination and escalation, as needed.
- Ensuring cross-functional PTR deliverables, including assignments delegated by the Technical Regulatory Leader (TRL) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
- Keeping the TRL/Squad fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
- Contributing to regulatory excellence and driving efficiency by finding opportunities, mitigating risks and supporting continuous improvement.
- Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments).
Who You Are:
- You are currently enrolled in a Bachelor’s Degree in life science subject areas (such as Health Science, Life Science, Chemistry, Biochemistry, or related fields). Preferably, candidates should be in their 3rd or 4th year of undergraduate study.
- Good understanding of the pharmaceutical or biotechnology industry and/or drug manufacturing process.
- Strong written and verbal communication skills
- Captures information and thinks through problems clearly and logically, and makes timely decisions
- Project management - consistently achieves multiple tasks and goals on-time
- As we continue to experiment with New Ways of Working, it is important to be able to demonstrate learning agility, teamwork & collaboration and decision making skills.
Additional Information:
- Duration ( 4 months), work term (Full time) and will begin in (May, 2025)
- Location: Based in Mississauga, Ontario.
- Our team follows a hybrid work structure (minimum 3 days in the office).
This position is not eligible for relocation support.
#SummerInternship2025
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.