At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.

Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to contribute to achieving our goal to develop and deliver life-changing medicines.

Position Type: 15-month Contract

Location: Mississauga, Head Office

Career Level: C

Are you detail oriented with a passion for Clinical Trials and Regulatory Compliance? Are you motivated to solve puzzles and improve processes? Do you love detailed work?

As an integral part of the regulatory team you will assist with Clinical Trial Applications (CTAs), regulatory strategies and maintain compliance with AZ corporate policies.

Responsibilities:

Ensuring regulatory input, protocol review and timely preparation, publishing, quality control, filing and approval of CTAs, Amendments and Notifications, including supporting of Externally-Sponsored Studies and CROs with filings and Health Canada review process. You are also responsible for following all formatting, standards and operating procedures, including electronic Trial Master File system requirements.

Supporting the delivery of optimal Health Canada approvals (time and quality), maintaining compliance and improving clinical trials’ and products’ potential and lifecycle in the Canadian marketplace.

Preparing and submitting submissions for safety and CMC updates, as well as filing and maintenance of drug master files.

Leading and supporting the submission review process with Health Canada (responding to clarifaxes).

Assisting in implementing strategies and tactics.

Facilitating and reviewing the preparation of complex submissions and conducting TA-specific research (as required).

Assisting with product divestments (as required).

Helping with preparation for Health Canada meetings, such as organizing meeting logistics, preparation of pre-meeting packages and slide development.

Initiating, reviewing and approving artwork (as required).

Aiding in the development of responses to Med Info, Clinical and Commercial requests and ATI requests.

Participating in cross-functional initiatives.

Reviewing regulatory submissions and documents for alignment with both HPFB and AZ requirements and standards (e.g., Electronic submission processes).

Develop, champion and maintain positive relationships with internal and external partners, including Health Canada.

Qualifications

• University degree or equivalent in a related (health science) discipline
• Some working knowledge of the Canadian regulatory environment and regulations, policies and guidelines
• Experience with Clinical Trial Applications
• Strong project and time management skills
• Strong written and verbal communication skills
• Commitment to collaboration
• Attention to detail
• Proficient in the use of Microsoft Office
• Customer-focused

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

• GTAA Top Employer Award for 6 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada
• Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
• Learn more about our culture: https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G

Are you interested in working at AZ? Apply today!

Date Posted

Closing Date

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.