Senior Regulatory CMC Leader – Vaccines (Remote)

Vaxcyte; United States; Remoto; USD 183.000 - 194.000; Tempo pieno

Descrizione del lavoro

Vaxcyte is seeking an experienced Regulatory CMC leader to define and execute global regulatory strategies for investigational products. You will lead preparation for CMC submissions and manage Health Authority interactions to ensure compliance across markets.

You will guide cross-functional teams, oversee documentation, and respond to regulatory queries while aligning with product development programs and timelines. This remote US role offers a competitive package and equity.

Competenze

• Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
• 9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
• Prior experience preparing/authoring CMC DS sections: BLA highly preferred, IND highly preferred, IMPD.
• Prior development or manufacturing experience is a plus.
• Experience with module 3.2S and 3.2P.
• 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.
• Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte’s achievement of business objectives.

Mansioni

• Represent Regulatory Affairs in internal cross-functional project teams and provide regulatory positions on CMC topics.
• Manage collection, review, coordination, and preparation of documentation for regulatory CMC submissions.
• Prepare responses to queries from regulatory authorities.
• Ensure conformance to commitments made with regulatory agencies.
• Collaborate with cross-functional project teams and external partners to develop regulatory strategies and identify regulatory risks.
• Coordinate responses to CMC-related queries from Health Authorities.
• Manage coordination, preparation, and timely submission of regulatory documents and filings.
• Review and approve change controls related to proposed product/process changes and assess their regulatory impact.
• Cultivate productive working relationships with the Regulatory team and other departments.

Conoscenze

Regulatory strategy

CMC submissions

Cross-functional collaboration

Regulatory timelines

Regulatory risk management

Formazione

Bachelor of Science in a scientific discipline

Strumenti

LIMS

SAP

TrackWise

Veeva

Descrizione del lavoro

Vaxcyte is seeking an experienced Regulatory CMC leader to define and execute global regulatory strategies for investigational products. You will lead preparation for CMC submissions and manage Health Authority interactions to ensure compliance across markets.

You will guide cross-functional teams, oversee documentation, and respond to regulatory queries while aligning with product development programs and timelines. This remote US role offers a competitive package and equity.