Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
About the Position
The Manager, Regulatory Operations is an integral member of the Regulatory Affairs team. The Manager, Regulatory Operations will be working with teams and individuals on developing and maintaining the regulatory submission plans for all submissions. The Manager, Regulatory Operations is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Manager provides regulatory operations expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submission. This position should be skilled in regulatory submission publishing, processes and support, Regulatory Information Management System (RIM), reporting and metrics, audit support, and other functions associated with US, and international regulatory activities.
This position will report to the Director, Regulatory Operations and will be based in Seattle, WA.
- Collaborate with teams and individuals, be the regulatory operations subject matter expert, plan and execute timely regulatory submissions in eCTD and paper formats in support of investigational and marketed products.
- Organize and maintain submission components associated with regulatory submissions, paper and/or electronic, as required. This may include, but not exclusive to, setting up templates, printing, and maintain records / data in the Regulatory Information Management (RIM) system.
- Coordinate and track delivery of required content with content owners for routine / maintenance submissions in all markets
- Provide advice on acceptability of regulatory submission plans, from a Regulatory Operation perspective
- Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed
- Develop and administer in-house training, as needed, to ensure optimal use of templates, processes, and tools critical to compiling submissions
- Provide support in software validation/migration/updates specific to systems in Regulatory Affairs.
- Lead or assist with other projects and activities (appropriate for this job level) as assigned by management, in support of the Regulatory Operations function.
- Contribute to development of process documentation including, SOPs, Work Instructions, or Best Practices
- Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, and ICH for regulatory submissions to ensure compliance
Qualifications and Education
- Minimum 5-8 years of Regulatory Operations experienced required
- Experience in managing and publishing regulatory submissions for investigational or marketed products to global health authorities
- Experience in managing complex projects
- Requires knowledge of global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada and ICH
- Technical experience in handling eCTD Publishing tools and ESG is required. Extensive experience with MS Office, Adobe Acrobat, publishing software, Adobe plug-in tools, Starting Point templates, DocuSign, and Veeva Vault is preferred
- Excellent verbal and written communication skills
- Ability to work independently with minimal supervision or direction
Why work for us?
Innovation. Act with Integrity. Collaboration. Care
We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
To learn more about Zymeworks Inc. and our current openings, please visit our website at https://zymeworks.bamboohr.com/jobs/.Apply Now