layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Project Manager, Regulatory CMC at Vaxcyte | LAYIQ

BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
PMP Certification and/or Project Management training desired.
8+ years of experience in the pharmaceutical or biotechnology industry with at least three years of relevant experience in a CMC organization and at least two years directly supporting regulatory submissions, including significant experience in a cross-functional team environment.
Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations, FDA/ICH regulatory requirements, and eCTD structure (Module 3 CMC content). Direct experience supporting or leading regulatory filings, including BLA and Prior Approval Supplements (PAS), required.
Prior experience as a liaison with external manufacturing organizations desired.
Demonstrated experience preparing, coordinating, and submitting regulatory filings such as BLA and Prior Approval Supplements (PAS), including managing authoring timelines, cross-functional review cycles, and health authority responses.
Familiarity with regulatory submission systems and publishing tools (e.g., Veeva Vault RIM/Submissions) a plus.
Expert analytical skills for integrating and interpreting interdisciplinary project information.
Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
Demonstrated ability to manage complex projects independently and ability to manage changes in processes, strategy, and competitive landscape.
Strong team management skills, including facilitation, conflict resolution, and team development.
Proven influence management and communication skills, at all levels of the organization.
Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project.
Working knowledge of Veeva and Smartsheet a plus.
Excellent written and oral communication skills.
All Vaxcyte employees require vaccination against COVID-19.
Other combinations of education and/or experience may be considered.
Reports to: Vice President, Project Management
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid (3 days per week onsite)

Senior Project Manager, Regulatory CMC

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