Regulatory Submission Specialist
Position Title: Regulatory Submission Specialist
Position Type: 20 month 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 expansive 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 cultivates 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 substantial impact where society needs it — health. We know the health of people, the planet and our business 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. We’re proud to say that our colleagues agree – 90% say AstraZeneca Canada is a ‘Great Place to Work’.
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 encourage alternative perspectives to push our thinking further, together.
What you’ll do
- Publish, compile, and record registrations of timely and accurate eCTD submissions to Health Canada. This includes, but is not limited to, the following:
- Management of all Canadian publishing, and registration activities
- Management of publishing timelines and resource estimates
- Maintain consistent and efficient submission preparation processes
- Ensure regulatory submissions and documents are aligned with both HPFB, ICH and AZ publishing requirements and standards
- Participate in the interpretation of guidelines and impact assessment to current work procedures
- Anticipate Regulatory consequences and advise project teams on publishing issues
- Participate in submission project planning meetings to provide support, expertise and guidance to achieve business outcomes
- Implement business solutions that:
- Accelerate time to submission and time to approval; and
- Maximize efficiency, performance and productivity
- Provide business system and document management support and training to Regulatory Affairs
- Support the testing and implementation of new publishing technologies or processes to support submission production
- Develop quality control processes to maintain or improve document and submission quality
- Participate in cross-functional initiatives
- Develop, cultivate and maintain positive collaborations with partners
- Manage change by proactively providing training and support to enhance RA proficiency through technology
- Coordinates the preparation and timely filings of patent forms in conjunction with regulatory submissions
- Coordinates Product Monograph updates
- Adhere to principles of Good Regulatory Practice
Essential for the role
- University degree or equivalent in a related subject area
- Ability to adapt to new technology quickly
- Ability to manage a multitude of tasks/responsibilities and ability to meet tight deadlines
- Strong project and time management skills
- Detailed oriented
- Strong written and verbal communication skills
- Commitment to collaboration
- Strong social skills
- Business knowledge and technical application of computer systems (e.g., MS Office, XML, document management systems, publishing systems, tracking systems)
- Analytical Skills
- Ability to handle sensitive, proprietary information in a confidential manner
- Ability to effectively communicate technical information to non-technical audiences
This is the place to make a significant impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 7 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/
- Browse AstraZeneca's YouTube channel to find out more about us:https://www.youtube.com/user/astrazeneca
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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.