Regulatory Affairs, Project Manager
Regulatory Affairs, Project Manager
Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
Position Type: Full Time Contract
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impactwhere society needs it —health. We know the healthof people, the planet and ourbusiness are interconnected,each impacting the others.
Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.
Regulatory Affairs and Quality Assurance Team
Be part of a global, winning team filled with the smartest minds. Our diversity is our strength, it reflects the variety of patients we serve. We strive to create a place where everyone is empowered to speak up and share ideas, and we welcome alternative perspectives to push our thinking further, together.
What you’ll do
- 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
Essential for the role
- 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
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
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
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.