Sr. Manager, Regulatory Affairs
This is the employer's own posting, not a copy on a job board.
What we know
Is it still open?
Confirmed still open
Last checked 2d ago — checked against the employer's own applicant tracking system, which is the company answering directly.
We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.
How old is it?
Posted 90d ago
The date the source published, not the day we noticed it (2026-06-16). Last seen at its source 3h ago.
Is it remote?
The listing says yes
The location field doesn't say remote, so our assessment is based on the title or the description. Read the listing before applying.
Who may apply?
United States
The description agrees: it names United States.
What the ad says
…Location: US - Remote Work Arrangement (may be adjusted based on busin…
Pay
$183k–194k/yr
Read out of the job description by us, not from a structured field. Shown in the posting's own currency and period; we never convert.
Skills named in the ad
Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.
Carried by 1 source
-
greenhouse employer's own board first seen 12d ago · last seen 3h ago
The listing
Join our Mission to Protect Humankind!
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 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.
Equal Opportunity
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.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.