Regulatory Affaris Associate Intern 12-Month Contract 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. 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 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 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.
Working knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines Strong project and time management skills Proficient in the use of Microsoft Office Customer-focused Advanced university degree (MSc or PhD) considered an asset Risk identification and management CDS regulatory assessments and Product Monograph updates) Knowledge of AstraZeneca global and local policies and procedures Business acumen, such as writing business proposals and project plans Knowledge of the pharmaceutical drug development process Knowledge of the Canadian Regulatory environment and Health Canada regulations, policies and guidance Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).
Advantages offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days.
Fixed Term
Contract/Temporary positions (excluding students) are offered a Contract Benefits Program. ~ annual Variable Pay Bonus/Short Term Incentive opportunity ~ eligibility to participate in our equity-based long-term incentive program (if applicable to role) ~ competitive Flex Benefits & Retirement Savings Program ~4 weeks’ paid vacation ~ annual Personal Days ~ Contract Benefits Program