Regulatory Affairs, Project Manager
Anticipated start date is January 2021
18 month contract, full-time
Mississauga, Head Office
As the Regulatory Affairs Project Manager, you provide regulatory input and direction to the Canadian Cross Functional Team and Global regulatory teams to build regulatory strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact a product's potential and lifecycle in the Canadian marketplace. You actively support the team to maximize efficiency, performance and productivity. You ensure your responsibilities are delivered in compliance with AZ Corporate responsibility policies.
Responsibilities will be:
Build and implement regulatory strategic plans including Regulatory Strategy Documents
Prepare, submit and resolve issues for approvals of NDSs and SNDSs
Maintain regulatory compliance of approved products
Plan and conduct Health Canada meetings to ensure positive outcomes; work with external contacts and participate in key external advisory boards
Build and release Health Professional and Public Communications
Review and approve promotional materials including artwork
Compile responses to ATI requests
Provide strategic and informed regulatory/business expertise across the organization as required
Influence the global development of products, representing the Canadian market, to mitigate regulatory risks in the development plans
Lead or participate in cross-functional and external initiatives
Ensure regulatory submissions and documents are aligned with both HPFB and AZ requirements and standards (e.g., Electronic submission processes)
Provide comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys
Provide expertise and support to junior staff members (associates, students and assistants) to positively encourage development and knowledge transfer
B.Sc. or equivalent in a related (health science) discipline; advanced degree (M.Sc. or Ph.D.) is an asset
Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines
Knowledge in one or more of the following key therapeutic areas CV-Metabolism, Oncology, and Respiratory/Immunology is ideal
Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries
Minimum 2 years regulatory project management experience
Proficient in the use of MS Office
Superior resolution skills, problem solving ability and innovative creative thinking
Excellent time management and organizational skills (able to manage multiple projects and priorities effectively)
Keen detail orientation to identify errors
Strong written and verbal presentation skills and adept at crafting business proposals and project plans
Ability to identify risk and build a plan to mitigate the risk
Positive interpersonal and relationship building skills with the ability to work effectively in a team both internally and externally
About AstraZeneca Canada:
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 quickly to inspire change. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new insights 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 achieve our goal to develop and deliver medicines.
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/
Are you interested in working at AZ? Apply today!
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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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 authorisation and employment eligibility verification requirements.