Project Manager, Regulatory Affairs

at  AstraZeneca

JOB DESCRIPTION

Prepares/executes global/regional regulatory tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Generates/project manages delivery, to time/quality of submissions. Demonstrates in depth knowledge of Regulatory compliances and submissions. Develops and builds good relationships with internal customers and Regulatory authorities, improving Regulatory outcomes.

TYPICAL ACCOUNTABILITIES

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
Provide regulatory input and direction to Brand and Global regulatory teams in order to deliver regulatory strategies, optimal Health Canada approvals (time and quality), maintain compliance and maximize a product’s potential and lifecycle in the Canadian marketplace.

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title include:

• Lead the development and implementation of regulatory strategic plans including Regulatory Strategy Documents
• Assess, prepare, submit and negotiate approvals for regulatory submissions with optimal outcome in line with cost recovery, business and regulatory requirements
• Maintain regulatory compliance of approved products
• Plan and execute Health Canada meetings including preparation of Key External Experts and Global/Local cross-functional teams
• Develop and finalize Health Professional/Public Communications as required
• Review and approve promotional materials and external communications
• Compile or coordinate responses to transparency requests (e.g. ATI, PRCI)
• Initiate and support artwork activities
• Support clinical trial applications as required
• Provide strategic and decisive regulatory/business expertise to Brand/Launch Teams and across the organization
• Influence the global development of products, representing Canadian regulatory environment and market, to mitigate regulatory risks in the development plans (as applicable)
• Ensure regulatory submissions and documents are compliant with both HPFB and AZ requirements and standards (e.g., electronic submission processes)
• Provide comments and stay abreast on emerging Canadian regulations/policies/guidelines/initiatives/surveys
• Actively create and promote collaboration with AstraZeneca Canada, Global Regulatory Affairs, Key External Experts and Health Canada to identify and act on opportunities combining forethought with action
• Actively support the RA department to maximize collaboration, efficiency, performance and productivity
• Provide guidance and support to junior staff members (associates, students)
• Adhere to principles of Good Regulatory Practice.
• Complete mandatory training in Cornerstone within specified timeframe.