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Mississauga, Ontario, Canada
Job reference: R-047486
Posted date: Mar. 25, 2019

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 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.

Position Title: Regulatory Affairs Project Manager

PositionType: Regular, Full time or 18-24 month secondment may be considered if a suitable candidte is identified. Relocation assistance will be provided but not fully supported.

Location: Mississauga, Head Office

Career Level: D

Are you motivated to solve puzzles and improve processes? Do you love detailed work? Are you passionate about project management?

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.

Your responsibilities will be:

  • Build and implement regulatory strategic plans including Regulatory Strategy Documents
  • Prepare, submit and negotiate of approvals of NDSs, SNDSs and NCs
  • Maintain regulatory compliance of approved products
  • Plan and conduct Health Canada meetings to ensure positive outcomes
  • Prepare Key External influencers for meetings, participate in Health Canada advisory boards and write informed opinions
  • 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

Your 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, Respiratory/Inflammation and Infection 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

Your strengths include:

  • Superior negotiation 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

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 a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca 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.

Do you know why Great People want to Work with us? Find out why:

Regulatory Affairs Project Manager

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