Sr. Manager, Regulatory Affairs

Vaxcyte•San Carlos, CA

1d•Remote

About The Position

Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Sr. Manager, Regulatory Affairs role is a hands-on position that involves both strategic and operational activities. This role is responsible for developing and executing multi-product global regulatory CMC strategies for investigational products, leading the preparation and filing of regulatory CMC submissions, and managing interactions with Health Authorities on CMC topics. The position also provides regulatory CMC guidance to cross-functional teams, ensures compliance with global regulatory requirements, and conducts routine regulatory surveillance to communicate new or changing regulations.

Requirements

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 experience.
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.
Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte’s achievement of business objectives.

Nice To Haves

Prior development or manufacturing experience is a plus.

Responsibilities

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