Vaxcyte

Vaxcyte

Sr. Manager, Regulatory Affairs

San Carlos, California, United States · Senior

Sponsorship not specified$183k-$194kDetected 29 days ago
SAPFDA RegulatoryMedical DevicesCommunicationCollaborationRegulatory Affairs

About the role

  • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
  • Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
  • Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

Responsibilities

  • This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions.
  • Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.

Nice to have

  • BLA highly preferred.
  • IND highly preferred.
  • Prior development or manufacturing experience is a plus.
  • Experience with module 32S and 32P.
  • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.

Compensation

  • $183,000 - $194,000 (SF Bay Area). Salary ranges for non-California locations may vary.
  • This role is not eligible for relocation assistance.
  • The compensation package will be competitive and includes comprehensive benefits and an equity component.

Benefits

  • Manages interactions with Health Authorities for CMC topics.

Company info

  • Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
  • This role is not eligible for relocation assistance.
  • We are an equal opportunity employer.
  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
  • Join our Mission to Protect Humankind!
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This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.