Job Description

About Our Company:At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, daring thinking, and innovation xe2x80x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to build a strong culture of collaboration and partnership by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely crafted with collaboration in mind, providing space where teams can come together to strategize, brainstorm, and connect on key projects.Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca is an excellent place to work. We know the health of people, the planet and our business are interconnected which is why wexe2x80x99re taking bold actions to address some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.Summary of Position:
As a Regulatory Affairs Associate, you will 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 improving a productxe2x80x99s potential and lifecycle in the Canadian marketplace.What Youxe2x80x99ll Do:

• Prepare, submit, and negotiate post-market submissions, such as SNDS for new indications, safety updates, Product Monograph template conversions, and Plain Language Labelling.
• Support Clinical Trial Applications with regulatory input, ensuring timely filings and approvals for Applications, Amendments, and Notifications.
• Maintain regulatory compliance for approved products, including Annual Notifications, internal Level changes, and post-approval commitments.
• Support the assessment and filing of CMC submissions as assigned.
• Assist in the submission review process with Health Canada, including responding to clarifaxes.
• Contribute to the development and implementation of regulatory strategies and tactics.
• Help prepare Supplemental New Drug Submissions and New Drug Submissions.
• Organize meeting logistics and prepare pre-meeting packages and slides for Health Canada meetings.
• Support operational activities such as labelling, publishing, and operations.
• Draft responses to Medical Information, Clinical, and Commercial requests as needed.
• Compile or coordinate responses to transparency requests like ATI and PRCI.
• Participate in cross-functional initiatives and therapeutic area-specific research.
• Ensure regulatory submissions and documents align with HPFB and AstraZeneca standards, including electronic submission processes.
• Provide feedback on emerging Canadian regulations, policies, guidelines, initiatives, and surveys.
• Build and maintain positive relationships with internal and external partners, including Health Canada.
• Actively support the Regulatory Affairs department to enhance efficiency, performance, and productivity.
• Adhere to Good Regulatory Practice principles.
• Complete mandatory training in Cornerstone within the specified timeframe.

What Wexe2x80x99re Looking For:

• 1-3 years of regulatory experience in the pharmaceutical or biotechnology industries.
• Familiarity with the Canadian regulatory environment and Health Canada regulations, policies, and guidelines.
• Bachelor's degree or equivalent in a related health science field.
• Strong problem-solving skills and innovative critical thinking, particularly in CDS regulatory assessments and Product Monograph updates.
• Understanding of AstraZeneca's global and local policies and procedures.
• Insight into AstraZeneca's operations, including the submission process.
• Business sense, including experience in writing business proposals and project plans.
• Comprehensive knowledge of the pharmaceutical drug development process.
• Proficiency in packaging design and product branding principles.
• Excellent project and time management abilities.
• Exceptional written and verbal communication skills.
• Experience in risk identification and management.
• Strong relationship management and negotiation skills.
• Detail-oriented with a focus on quality.
• Proficient in Microsoft Office.
• Customer-focused with a collaborative teamwork approach.

Who We Are:Great People want to Work with us! Find out why:At AstraZeneca, we are committed to investing in our employees' growth and development. Our strength lies in our global, diverse network. We work seamlessly together, adapting and learning together to find new solutions that accelerate our impact. We value wellbeing and flexibility, creating an environment where everyone feels at home from the moment they join. We are trusted partners across the enterprise, driving growth through our niche expertise.Ready to make an impact? Apply now to join our team of specialists that is valued and essential to the growth of AstraZeneca!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com ( ).Date Posted 26-Nov-2024Closing Date 03-Dec-2024AstraZeneca 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.

AstraZeneca