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 Associate Director, Regulatory Operations is an integral member of the Regulatory Affairs team. The Associate Director Regulatory Operations will be working with teams and individuals on developing and maintaining the regulatory submission plans for all submissions. The Associate Director 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 Associate Director 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.
Qualifications and Education
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/.
NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.
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