Manager, Regulatory CMC (Cell Gene Therapy)

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.

Introduction to role

The Manager CMC Regulatory Affairs is responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory CMC technical writing objectives are met for the innovative pipeline of early and late-stage T cell therapies. This position is hybrid and may have managerial responsibilities in the future. The role reports to the Senior Director, CMC Regulatory Affairs.

Accountabilities

• Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications.
• Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
• Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
• Ensure submissions are complete and accurate and comply with applicable regulatory requirements and expectations.
• Support the development and maintenance of regulatory templates, best practices, and procedures.
• Perform other responsibilities.
• Support hiring, leading and managing workflow.

Essential Skills/Experience

• Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, handle, and prioritize multiple projects and work independently.
• Excellent communication and collaboration skills to work in a fast paced start up environment.
• Proficient leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
• Ability to deal with time demands, incomplete information or unexpected events
• Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize.

Desirable Skills/Experience

• BA/BS degree in life sciences required, advanced degree preferred (MS, PharmD).
• Experience of 8+ years with BS/BA; 6+ years with MS/MA.
• Prior experience in cell/gene therapy.
• The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
• The candidate must have CTD Module 3 authoring skills.
• Experience in IND, IMPD, BLA, MAA filings.

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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.

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