CMC Regulatory Affairs Manager

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.

We are looking for  Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Managers to join our organisation.

Chemistry, Manufacturing, and Controls (CMC)

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.

With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.

We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the commercial lifecycle; including Clinical Trial Applications (CTAs), Marketing Authoring Applications (MAAs) and all post approval activities improving the value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and mentorship required to advise the development of robust plans for change initiatives.

What you’ll do

Being a CMC RA Manager, means that you will effectively manage 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. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle.

As a CMC RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with collaborators and project team members to ensure that relevant timelines and regulatory commitments are communicated. The accountabilities also include responsibility for change management as assigned and to ensure the learning from own projects are shared with other co-workers/within the function.

Responsibilities:

• Be accountable for delivering “submission ready” CMC modules to internal and external regulatory partners in compliance with relevant AstraZeneca systems and procedures, ensuring submission quality
• Manage/Lead the preparation and delivery of CMC contributions throughout the product lifecycle
• Maintain regulatory databases related to submissions
• Communicate Health Authority approval status
• Develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions
• Support the agreed strategy to employ fit for purpose content, applying regulatory intelligence to optimize proposed submission content
• Participate in regulatory execution and delivery meetings and communicate and provide relevant updates to the CMC team
• Contribute to business process optimization activities to reduce waste and ensure efficiency
• Continually evolve and develop regulatory expertise through proactive recording and communication of Health Authority interactions, responses and commitments
• Apply GxP principles according to the stage of product lifecycle

Essential for the role:

• Bachelor’s degree in Science, Regulatory Sciences or Pharmacy
• Breadth of knowledge of manufacturing, project, technical and regulatory management IT Skills
• Stakeholder & Project management
• CMC Regulatory dossier knowledge
• Project management expertise with the ability to adapt to changing situations to ensure on time delivery

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are 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 AZCHumanResources@astrazeneca.com.

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 believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. 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.