Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices)
9+ years of experience in the vaccine or biotech industry or equivalent
Prior experience preparing/authoring CMC Drug Substance sections (BLA or IND preferred)
Development or manufacturing experience is a plus
Experience with module 32S and 32P
Proficient in software tools (LIMS, SAP, TrackWise, Veeva)
Strong ability to manage multiple deadlines with accuracy and efficiency
Responsibilities
Represent Regulatory Affairs in cross-functional project teams and improvement initiatives
Manage documentation for regulatory CMC submissions, including trackers for requests and timelines
Prepare responses to queries from regulatory authorities
Ensure conformance to commitments made with regulatory agencies
Collaborate with cross-functional teams to develop regulatory strategies
Coordinate and prepare regulatory documents for timely submission
Review and approve change controls related to product/process changes
Benefits
Comprehensive benefits package
Equity component in compensation
Remote working opportunity
Full Job Description
Summary:
A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. Essential Functions:
Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various 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 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 coordination, preparation, and timely submission of regulatory documents and filings.
Review and approve change controls related to proposed product/process changes and asses 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.
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 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.
Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte's achievement of business objectives.
Reports to: Executive Director, Regulatory CMC
Location: US - Remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $183,000 - $194,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Relocation:
This role is not eligible for relocation assistance.
About Vaxcyte
Vaxcyte is a clinical-stage biotechnology company developing a new generation of vaccines to address some of the most important and deadly infectious diseases worldwide. The company's cell-free protein synthesis platform, comprising the XpressCFTM platform, is capable of rapidly generating protein antigens that can be used in vaccines to protect against bacterial and viral pathogens. Vaxcyte's lead vaccine candidate, VAX-24, is a preclinical, 24-valent pneumococcal conjugate vaccine (PCV) being developed for the prevention of pneumococcal disease. The company is also developing VAX-XP, a PCV with expanded serotype coverage, as well as vaccines for Group A Streptococcus, Group B Streptococcus, and Lyme disease.
