Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 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 teamwork 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 teamwork 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 environment and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Job Responsibilities

• Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
• Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
• Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
• Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
• Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
• Writing scripts and participating in system testing in support of system releases

• Business administration of systems, e.g. provision of system access, application of security models and managing change.

• Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
• Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
• Ensure the learning from own projects are shared with other colleagues/within the functions.

Education, Qualifications, Skills and Experience

• Foundational / Associate degree in Science, Regulatory Sciences or Pharmacy
• Team working skills
• IT Skills
• Bachelors degree in Science, Regulatory Sciences or Pharmacy
• 1 year experience in Regulatory / Drug development (Industry or Health Authority)
• Basic Knowledge of the drug development process and regulatory submissions
• Understanding of current regulatory CMC requirements
• Experience in Pharmaceutical production , reg affairs, quality assurance, R&D
• Basic Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies

Great People want to Work with us! Find out why:

Are you interested in working at AZ, apply today!

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 .

Date Posted 26-Jun-2023

Closing Date 02-Jul-2023

AstraZeneca 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