Regulatory Affairs Manager (9-month contract)

This is a 9-month contract At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.Accountabilities/Responsibilities:Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:Submission delivery strategy of all dossiers and all application types per market and /or <region.Review> of documents (e.g. response documents, study protocols, PSRs, etc.).Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.Use and share guidelines, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.Develop, complete and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.Identify regulatory risks and propose mitigations to Lead RPM and cross functional <teams.Support> operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of GRO, MCs, CROs and/or alliance partners where relevant.Provide coaching, mentoring and knowledge sharing within the RAM skill group.Contribute to process improvement.Use available AI tools effectively and responsibly to improve efficiency, streamline routine activities and support high quality regulatory deliverables.Minimum Requirements –Education and ExperienceRelevant University Degree in Science or related discipline2-4 years of experience in Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experienceGeneral knowledge of drug developmentStrong project management skillsLeadership skills, including experience leading multi-disciplinary project teamsPreferred ExperienceRegulatory experienceManaged regulatory deliverables at the project levelThorough knowledge of the drug development processKnowledge of AZ Business and processesSkills and CapabilitiesExcellent written and verbal communication skillsCultural awarenessScientific knowledge sufficient to understand regulatory issues and facilitate scientific discussionsProficiency with common project management (e.g., MS Project) and document management toolsAbility to work independently and as part of a teamInfluencing and stakeholder management skillsAbility to analyze problems and recommend actionsContinuous Improvement and knowledge sharing focusedInternal and External Contacts/CustomersGlobal Regulatory Leads (GRLs)Regional Leads (eg, US, EU international RADs)Lead RPMRegulatory skill groups in ORSS, Late R&I and Late CVRMOther R&D functionsMarketing CompaniesHealth AuthoritiesExternal collaboration partnersReporting RelationshipDirect Reports - NoneIndirect Reports -NoneGreat People want to Work with us! Find out why:GTAA Top Employer Award for 11 yearsTop 100 Employers AwardCanada’s Most Admired Corporate CultureLearn more about working with us in CanadaView our YouTube channelAre you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing <[email hidden]>.#LI-Hybrid⠀Annual base salary for this position ranges from 107,196.80 to 140,695.80.AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique <circumstances.In> addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.We are using AI as part of the recruitment process.This advertisement relates to a current vacancy.