Senior Regulatory Operations Associate/Publisher

Regulatory Vancouver, BC Canada


Description

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.

Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.

This position will report to the Director, Regulatory Operations and will be based in Vancouver, BC or Seattle, WA.

Key Responsibilities

  • Support Regulatory Affairs team in planning, publishing, submission, and archive of regulatory documents.
  • Prepare and submit eCTD and non-eCTD submissions of varying complexity to IND/CTA and BLA/MAA applications
    • Ensures compliant, high quality, timely submissions in accordance with current and emerging Health Authority guidance across multiple regions, including, but not limited to US and Canada.
    • Publish documents intended for regulatory submissions in accordance with company style and relevant guidance documents to ensure they meet requirements for electronic submissions and optimal global utilization.
    • Prepare and publish regulatory submissions in eCTD format, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials and meeting packages.
  • Format MS Word and Adobe Acrobat files to a state of submission-readiness
  • Work across company disciplines and represent Global Regulatory Operations on assigned project and/or task teams to effectively communicate and drive timings and deliverables.
  • Provide support to Regulatory Affairs and other cross functional areas
  • Project stakeholders in the creation of submissions documents
  • Manage and maintain correspondence and other records in regulatory tracking system
  • Coordinate exchange of records using document-sharing platforms
  • Contribute to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommend and help implement associated process improvements
  • Maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes related to the electronic Common Technical Document.
  • Maintain records in Regulatory Information Management (RIM) system.

Qualifications and Experience

  • BA or BS in a related field strongly preferred. An equivalent combination of education and experience may be considered.
  • A minimum of 5 years of direct experience with publishing, compiling, preparing and QC of documents for eCTD submissions.
  • Demonstrates a working knowledge of Regulatory Information Management system and publishing technologies. Experience with ISIToolBox, Starting Point templates, and Veeva Vault a plus.
  • Ability to work independently with moderate supervision on multiple projects simultaneously.
  • Detail oriented with creative problem solving and troubleshooting skills.
  • Strong written and verbal communication skills.
  • Strong team building skills.
  • Exceptional interpersonal skills with the ability to work individually and within multi-disciplinary teams.
  • Ability to travel up to 10%.
  • Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

Why Work for Us? 

Innovation. Act with Integrity. Collaboration. Embrace Diversity. 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.

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.