Regulatory Affairs Associate Intern

AstraZeneca GmbH; Mississauga; On-site; CAD 43,000 - 56,000; Full time

Job summary

AstraZeneca is seeking a Regulatory Affairs Associate Intern for a 12-month contract in Canada. You will assist with global/regional tactical submission plans, support Health Canada submissions, and help maintain regulatory documents under local and global codes.

You will collaborate with colleagues, develop relationships, and participate in cross-functional initiatives, including digital projects. A university degree in health sciences and knowledge of Health Canada regulations are preferred,

Qualifications

• 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 and teamwork.
• Detail oriented and customer-focused.

Responsibilities

• Assist with global/regional tactical submission plans on allocated projects/products.
• Support Health Canada submissions, including authoring and coordinating responses.
• Assist with preparation for Health Canada meetings and slide development.
• Participate in cross-functional initiatives and digital/AI projects.
• Adhere to regulatory best practices and complete mandatory training.

Skills

Strong project management

Written and verbal communication

Interpersonal skills

Detail oriented

Microsoft Office

Customer-focused

Teamwork

Education

University degree or equivalent in a health science discipline

Advanced degree (MSc/PhD) considered an asset

Tools

Microsoft Office

Job description

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.

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

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 Benefits Program

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.