Regulatory Licensing Associate (24 Month Contract)
Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years. We pride ourselves on creating a collaborative culture that champions knowledge-sharing, entrepreneurial thinking and innovation – 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 create 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 designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our commitment to sustainability is also central to our culture 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’re taking bold action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
The Regulatory Licensing Associate will be responsible for the preparation, submission and securing the approval of Drug Establishment License (DEL) applications in support of New Drug Submissions and Post-Approval Variations. The individual will work closely with the Regulatory CMC team for the DEL maintenance and registration compliance in adherence with the current regulations. The Regulatory Licensing Associate will also provide overflow support to the Regulatory CMC function to ensure delivery of optimal Health Canada approvals, maintain compliance and enhance productivity.
- Prepare high quality DEL applications, including the procurement and assembly of submission-ready components in adherence with the DEL Regulations, to support Establishment Licensing information for New Drug Submissions and post-approval variations related to supply chain plant/site changes.
- Assist in the development of Establishment License (EL) submission strategies with a strive to deliver DEL approvals in timely manner to support business objectives.
- Participate in Establishment License-related interactions, meetings and negotiations and facilitate submission approvals through effective communication with HC.
- Maintain DEL registration compliance for all marketed products to support ongoing/timely importation and distribution in Canada.
- Help supervise changes to Regulatory environment (regulations, guidelines, policies, etc.) as advised by Manager.
- Maintain a high level of technical understanding of compliance and regulatory requirements related to Establishment Licensing and supply chain plant/site changes in order to handle risks.
- Work with local and global Regulatory Chemistry/Manufacturing/Controls (CMC) to ensure alignment between the Establishment Licensing information and the regulatory CMC dossier.
- Responsible for continuous improvement of processes related to Canadian requirements for Establishment Licenses.
- Provide feedback on draft HC guidelines/legislation/policy associated to Establishment Licensing and supply chain plant/site changes.
- Provide overflow support to the Regulatory CMC, Therapeutic Areas, Operations and/or QA areas, as required.
- Develop, cultivate and maintain positive relationships with all stakeholders involved in the lifecycle management of our brands.
- Conduct activities and interactions consistent with What we value 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.
- B.Sc. or equivalent in a related (chemistry, engineering, biology) discipline
- Previous experience with Establishment License requirements and submissions an asset
- A minimum of 2 years regulatory, QA or supply chain management experience in the pharmaceutical or biotechnology industries.
- Experience with risk identification and risk management.
- Excellent at project management, time management and organizational skills (ability to lead multiple projects and priorities optimally).
- Current knowledge of DEL regulations, cGMP, CMC Regulatory and ICH guidelines.
- Solid understanding of the Canadian regulatory environment and Health Canada.
- Able to balance and progress multiple projects across all therapeutic areas.
- Excellent communication skills, both written and verbal.
- Strong computer skills (MS Office, Adobe Acrobat).
- Sophisticated problem-solving ability and innovative thinking.
- Attention to detail, balanced with understanding of business objectives.
- Commitment to collaboration.
- Therapeutic area, product and brand knowledge
- Knowledge of international regulatory activities and trends
- Previous experience with post-approval change management for biologic and small molecule products
- Knowledge of Drug substance/Drug product manufacturing processes
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 8 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
- Browse AstraZeneca's Oncology YouTube channel to find out more about our focus:https://www.youtube.com/playlist?list=PLgfkdJlwmkT7Sj9A_N6J_9OKcnBW5eNyy
Are you interested in working at AZ, apply today!
AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.
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 emailingAZCHumanResources@astrazeneca.com.