Manager, Regulatory Operations
Manager, Regulatory Operations
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. 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 responsible for supporting the preparation and submission of electronic regulatory documents (eCTD) in compliance with global health authority requirements. The position will ensure timely and compliant submissions of the highest quality, including clinical trial, i.e. CTAs, INDs, amendments, meeting briefing packages, periodic reports, safety reports and marketing applications (BLA/NDS/MAA).
This position will report to the Vice President of Regulatory Affairs and will be based in Seattle, WA.
- Responsible for the preparation, delivery and archiving of high quality global regulatory submissions in accordance with company standards and timelines.
- Ensure submissions and related documentation are prepared in eCTD format and in compliance with applicable health agency regulations and guidelines.
- Performance of high-level formatting in both word and PDF files, including the creation of bookmarks/hyperlinks, file optimization, optical character recognition, etc.
- Review/validate submissions for compliance with technical requirements.
- Maintain submission scheduling calendar to allow timely completion of projects.
- Participate in submission team meetings.
- Maintain the corporate submissions style guide and templates and ensure their use for regulatory submission documents.
- Advise on regional and technical requirements for submission documents and provide answers to technical questions for submissions as needed.
- Support the implementation of necessary regulatory publishing systems, including assistance with validations, qualifications and verifications of the systems.
- Troubleshoot and resolve some technical issues with business-critical systems applications.
- Maintain effective relationships with external publishing vendors/ contractors to help manage the regulatory submission workload.
- Contribute to process improvement initiatives.
- Maintain the files for electronic regulatory correspondence, ensuring that all communications are properly archived.
- Contribute to the preparation and implementation of publishing processes and standards, and the updating/creation of the respective departmental SOPs and guidelines.
- Stay current with relevant global regulatory submission requirements and publishing best practices.
Qualifications and Experience
- Bachelor’s degree.
- 7+ years of pharma/biotech industry experience with 5+ years of in-depth Regulatory Operations experience.
- Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for submission types (i.e. IND, CTA, BLA, NDS, MAA, PSUR, DSUR, etc.).
- Experience in compilation and publishing of US FDA eCTD submissions is required and experience with ex-US electronic submissions is highly desirable.
- Detailed knowledge of and experience managing eCTD publishing systems, EDMS technology, publishing software and tracking databases.
- Detailed knowledge of clinical/nonclinical data standards (ADaM, SDTM, SEND).
- Thorough understanding of the submission production process from beginning to end.
- Strong knowledge of US and other major global (ICH, EU, Asian) regulatory requirements and standards and a thorough and current understanding of appropriate regulations.
- Strong knowledge of Microsoft Office suite, Adobe Acrobat and Plug-Ins, EDMS, eCTD publishing tools, eCTD validation and viewing tools.
- Ability to multi-task while paying close attention to detail and meeting deadlines.
- Ability to work independently and as part of a team to accomodate changing timelines and priorities.
- Excellent project management and organization skills.
- Solutions oriented and pragmatic with analytical thinking and problem-solving skills.
- Excellent communication and interpersonal skills.
Why Work for Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.co.uk/jobs/view.php?id=152 . Due to the high volume of applicants, only those selected for interviews will be contacted.