About the role#
The Regulatory Affairs Associate Intern supports the registration and maintenance of products at AstraZeneca. You will assist the regulatory team in implementing strategies and ensuring compliance with local and global standards. This role involves working on submission plans, coordinating with Health Canada, and supporting cross-functional initiatives.
What you'll do#
- Assist with global and regional tactical submission plans.
- Support the preparation of Clinical Trial Applications, Supplemental New Drug Submissions, and New Drug Submissions.
- Help with the submission review process, including authoring and coordinating responses to Health Canada.
- Organize logistics and materials for Health Canada meetings.
- Participate in cross-functional projects and support digital or AI initiatives.
- Provide feedback on emerging Canadian regulations and policies.
- Build relationships with internal customers and support the Regulatory Affairs department.
- Report potential compliance issues and adhere to Good Regulatory Practice.
What you'll need#
- A university degree in a health science discipline.
- Working knowledge of the Canadian regulatory environment, including Health Canada policies and guidelines.
- Strong project management, time management, and communication skills.
- Proficiency in Microsoft Office.
- A detail-oriented approach and a commitment to teamwork.
- Customer-focused mindset.
- An advanced degree (MSc or PhD) is considered an asset.
- Experience with risk identification, problem-solving, and business acumen is beneficial.
- Familiarity with the pharmaceutical drug development process and packaging design principles is preferred.
Location & details#
- Location: Mississauga, Ontario, Canada.
- Work Modality: On-site.
- Employment Type: Full time.
- Compensation: The annual base salary ranges from 42,908.00 to 56,316.75 CAD.
About AstraZeneca
AstraZeneca is a public pharmaceutical manufacturing company. It focuses on research, development, and global business operations. The company maintains offices in Cambridge and Sodertalje. It employs over 80,000 people.
How to get in at AstraZeneca
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