Innovation & Regulatory Affairs Project Manager

1 week ago


Mississauga, Ontario, Canada AstraZeneca Full time

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 role holders project lead all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer, including publishing of clinical and marketing regulatory documents.

They project lead global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle.

The role holder will chip in and lead the regulatory CMC components of business-related projects.

They will have effective levels of interactive communication with collaborators and project team members to ensure relevant timelines and regulatory commitments are communicated.

They will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new mentorship, policy, and processes


Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; Accountable for delivering "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.

Leads/represents PT&D and Pharm Sci on cross-functional work streams
Raise change requests (ANGEL), manage, escalate & input into the cross functional vote.

Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.

Apply GxP principles according to the stage of product lifecycle
Responsibility for change management as assigned.
Demonstrate research skills in understanding regulations, and guidance from different regulatory agencies
University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
Breadth of knowledge of manufacturing, project, technical and regulatory management.
Stakeholder & Project management
Regulatory knowledge
Knowledge of the drug development process and regulatory submissions
Understanding of current regulatory CMC requirements
Direct/indirect Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or sophisticated biologic products

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 .

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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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