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Location:
Mississauga, Ontario, Canada
Job reference: R-049132
Posted date: May. 03, 2019
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At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing 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 single 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 building a dynamic, inspiring 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 have a passion for science and are driven to always put patients first. Join us and be part of a phenomenal place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.

Position Title: Regulatory Affairs Publisher

Position Type: 24 month Contract

Location: Toronto

Career Level: C

Are you motivated to make a difference in your career? Do you enjoy collaborating with colleagues and the broader team? This role will allow you to execute regulatory operational strategies and tactics to deliver optimal HC approvals, maintain compliance and maximize the potential of each product throughout its life cycle.

Responsibilities:

In your position:

  • You will publish, compile, and record registrations of timely and accurate 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 a 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

  • You thrive to implement business solutions that accelerate time to submission and time to approval; and maximize efficiency, performance and productivity
  • You provide business system and document management support and training to Regulatory Affairs and Quality Assurance
  • You actively support the testing and implementation of new technologies or processes to support submission production
  • You are eager to develop quality control processes to maintain or improve document and submission quality
  • You enjoy participating in cross-functional initiatives
  • Develop, champion and maintain positive relationships with stakeholders
  • Lead change by dedicatedly providing training and support to enhance RA proficiency through technology
  • You coordinate the preparation and timely filings of patent forms in conjunction with regulatory submissions
  • You handle Product Monograph updates with CPS and Translation

Qualifications:

  • You possess a University degree or equivalent in a related discipline
  • You have a strong ability to adapt to new technology quickly
  • You have the aptitude to lead a multitude of tasks/responsibilities and ability to meet tight deadlines
  • You have strong project and time management skills
  • You are passionate about details
  • Written and verbal communication is one of your strengths
  • You are committed to collaboration within teams
  • You are customer-focused
  • You come equipped with business knowledge and technical application of computer systems (e.g., MS Office, XML, document management systems, publishing systems, tracking systems)
  • Analytical Skills
  • Consistent record of handling sensitive, proprietary information in a confidential manner
  • You successfully communicate technical information to non-technical audiences

Next steps – Apply today

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager will know that you feel well qualified for this position. If you know someone who would be an excellent fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. We will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Great People want to Work with us, find out why:

GTAA Top Employer Award for 5 years: https://content.eluta.ca/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/

Total Rewards for employees: https://www.astrazeneca.ca/en/working-at-az-canada/Total-Rewards.html

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Regulatory Affairs Publisher
Regulatory

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