Manager Regulatory CMC Cell Gene Therapy
Manager Regulatory CMC Cell Gene Therapy
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1 Vacancy
Job Description
At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledgesharing 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 facetoface 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 were 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 crossfunctional 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 latestage 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 crossfunctional 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 multifunctional 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 highfunctioning teams.
- Ability to deal with time demands incomplete information or unexpected events
- Attention to detail required.
- Outstanding organizational skills with the ability to multitask 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.
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 11 years
- Top 100 Employers Award
- Canadas 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.
#LIHybrid
Date Posted
24Apr2025Closing Date
01May2025AstraZeneca 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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Manager
Employment Type
Full-Time
