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Associate Director, Regulatory CMC

VaxcyteSan Carlos, California, United StatesNew
On-site Full-time $180K/yr - $210.5K/yr

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Experience Level

Experience

Qualifications

Essential Responsibilities:Oversee the preparation and review of CMC components of global regulatory submissions, including communication with regulatory agencies. Participate as a key member of technical development teams, applying in-depth knowledge of EMA, FDA, ICH, and global regulations to ensure CMC compliance. Define CMC content requirements for regulatory submissions and lead compliance initiatives.

About the job

Vaxcyte, based in San Carlos, California, is a clinical-stage vaccine company working to advance vaccines that address serious bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The team values creative thinking, ambitious goals, kindness, and integrity as it pursues new solutions in vaccine development.

Role overview

The Associate Director, Regulatory CMC, plays a key role in both strategy and execution. This position develops and implements global regulatory CMC strategies for investigational products. The role involves leading the preparation and submission of regulatory CMC documents, managing communications with health authorities, and guiding cross-functional teams on regulatory CMC matters.

Main responsibilities

  • Develop and execute global regulatory CMC strategies for investigational products.
  • Lead the preparation and submission of regulatory CMC documents.
  • Manage communications with health authorities regarding CMC topics.
  • Provide regulatory CMC guidance to cross-functional project teams.
  • Ensure compliance with global regulatory requirements.
  • Conduct ongoing regulatory surveillance to keep the team informed of changes in regulations.

About Vaxcyte

Vaxcyte is at the forefront of vaccine innovation, driven by a passion for protecting public health through the development of high-fidelity vaccines that address the pressing challenges posed by bacterial infections. Our team is dedicated to scientific excellence and collaboration, working tirelessly to create solutions that will make a lasting impact on global health.

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