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Regulatory Affairs Manager-Late CVRM

AstraZeneca GmbH

This is a Contract position in Ottawa, ON posted August 4, 2022.

Headquartered in Mississauga, Ontario, AstraZeneca has been recognized as a Greater Toronto Area Top Employer for eight straight years.

We pride ourselves on crafting a collaborative environment that champions knowledge-sharing, bold thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

To best support our employees in balancing personal and work commitments, we’ve adopted a hybrid model of working that gives employees flexibility in how they lead their time.

Our head office and BlueSky Hub in downtown Toronto are purposely crafted with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

As a Regulatory Affairs Manager (RAM), you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Late CVRM drives late-stage development of our innovative pipeline, redefining exciting science into valued new medicines and ensuring patients around the world can access them.

Position Description: The (RAM) is a regulatory specialist with project management capabilities responsible for owning the end-to-end planning, coordination, and execution of assigned results.

The RAM supports in the execution of regulatory submissions, identifying submission risks and opportunities, while leading simple through more ambitious regulatory applications and managing procedures through approval.

The RAM provides regulatory expertise and mentorship on procedural and documentation requirements to Global Regulatory Execution Teams, Global Regulatory Strategy Teams 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 as defined by Health Authorities for assigned deliverable(s) including: Project Manage submission delivery of all dossiers and all application types per market and /or region.

Review of documents (e.g.

response documents, study protocols, Periodic Safety Reports, etc.).

Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.

Use and share standard processes during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.

Lead and / or support in to the planning, preparation (including authoring of Regulatory documents eg Cover Letters, Health Authority Forms, etc) and delivery of simple and more sophisticated submissions throughout the product’s life cycle from either a global and/or regional perspective.

Develop, implement and maintain submission delivery plans, content plans, and proactively provide status updates to designated partners.

Coordinate the input, maintenance and revision in project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.

Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.

Support operational and compliance activities for assigned results, including generating work requests and submission content plans, submission tracking, Trial Master File, and document management applying the support and input of internal and external partners where relevant.

Provide help, mentorship and knowledge sharing within the RAM skill group.

Contribute to process improvement.

Minimum Requirements –Education and Experience: BS/BA in Life Science or related field or 4 years relevant biopharmaceutical experience in lieu of 2 years of regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience General knowledge of drug development Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams.

Preferred Experience 3-5 years of Regulatory project experience in biopharmaceutical environment Lead regulatory objectives at the project level Detailed knowledge of the drug development process RAC certification Phenomenal People want to Work with us Find out why: GTAA Top Employer Award for 8 years: Best Workplace Culture Award at the 2018 Canadian HR Awards: Learn more about our culture: Browse AstraZeneca’s Oncology YouTube channel to find out more about our focus: Are you interested in working at AZ, apply today AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve.

In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is a critical requirement of all positions at AstraZeneca.

As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship.

You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

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 .