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
Team-oriented 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
Annual base salary for this position ranges from 42,908.00 to 56,316.75.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. 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. The range provided in this posting represents an offer pay range used in a majority of situations.
The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
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).
Benefits 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 Perks Program
We are using AI as part of the recruitment process.