Regulatory Affaris Associate Intern
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
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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.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
AstraZeneca Mississauga, Ontario, CAN Office
Mississauga, Canada, 0
AstraZeneca Toronto, Ontario, CAN Office
Toronto, Canada, 0
