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Regulatory Affairs, Project Manager

Местоположение Миссиссога, Онтарио, Канада Идентификатор вакансии R-090918 Дата публикации 09/24/2020

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

Qualifications include:

  • 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

Strengths include:

  • 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:

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.

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