Regulatory Affairs Associate Intern

AstraZeneca • Mississauga • 14h ago

AstraZeneca Canada: Headquartered in Mississauga, Ontario, we’ve recently been recognized as one of Canada’s Most Admired Corporate Cultures as well as Greater Toronto Area’s Top Employers for 8 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others. Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond. Assists with global/regional tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Fluent with submission compilation, publishing and approval information processes and tools. Seeks opportunities and develops "rapport" with immediate colleagues to formulate relationships within the organisation. Supports the Regulatory team in all the activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures. Accountabilities: Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance. Support the delivery of optimal Health Canada approvals (time and quality) and product labelling (packaging artwork) while maintaining compliance and maximizing a product’s potential and lifecycle in the Canadian marketplace. Assist with the submission review process with Health Canada (authoring and coordinating clarifax responses) Assist in implementing regulatory strategies and tactics Assist with the preparation of Clinical Trial Applications, Supplemental New Drug Submissions and New Drug Submissions, Notifiable Changes and Level 3 and 4 Changes Assist with the preparation for Health Canada meetings, such as organizing meeting logistics, preparation of pre-meeting packages and slide development Participate in cross-functional initiatives including therapeutic area-specific research as assigned Support digital/AI projects and initiatives Provide comments and stay abreast on emerging Canadian regulations/policies/guidelines/initiatives/surveys Build and grow positive relationships with internal customers Actively support the Regulatory Affairs department to maximize efficiency, performance and productivity Adhere to principles of Good Regulatory Practice. Complete mandatory training in Cornerstone within specified timeframe. Essential Skills/Experience: University degree or equivalent in a related (health science) discipline Working knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines Strong project and time management skills Strong written and verbal communication skills Interpersonal skills Commitment to teamwork Detail oriented Proficient in the use of Microsoft Office Customer-focused Desirable Skills/Experience: Advanced university degree (MSc or PhD) considered an asset Risk identification and management Problem solving ability and innovative strategic thinking (i.e. CDS regulatory assessments and Product Monograph updates) Knowledge of AstraZeneca global and local policies and procedures Knowledge of AstraZeneca Operations, including the submission process Collaborative teamwork Business acumen, such as writing business proposals and project plans Relationship management skills Negotiation skills Knowledge of the pharmaceutical drug development process Knowledge of the Canadian Regulatory environment and Health Canada regulations, policies and guidance Knowledge of packaging design and product branding principles What to Expect: This 12-month paid contract hybrid-role is based in Mississauga, starting January 2026 with flexible onsite arrangement 3-days-a-week across the Mississauga and Toronto offices. This is a developmental opportunity designed to prepare you for future growth at AstraZeneca, working in partnership with a diverse range of colleagues and business areas. Great People want to Work with us! Find out why: Canada Top Employer Award for 10 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada#gta Learn more about our culture: https://careers.astrazeneca.com/values-behaviours Browse AstraZeneca's YouTube channel to find out more about us: https://www.youtube.com/user/astrazeneca Are you interested in working at AZ, apply today! If you are interested in this position, please submit your resume. If you wish, you may also submit a cover letter indicating your interest and availability. There is no need to submit any additional documentation such as transcripts or marksheets. AstraZeneca is committed to diversity and inclusion and providing a workplace that is free from discrimination. We welcome applications from candidates who self-identify as Black, Indigenous or person with disability. Date Posted 14-Oct-2025 Closing Date AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.