Associate Director, Regulatory CMC
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 1d 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 53d ago
The date the source published, not the day we noticed it (2026-07-23). Last seen at its source just now.
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 states no restriction of its own. This is the source's own tag.
Pay
$180k–210.5k/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 11d ago · last seen just now
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:
- Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies
- Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance
- Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements
- Provides CMC regulatory guidance to cross-functional teams and key stakeholders
- Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development
- Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects
- Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development
- Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise
Requirements:
Bachelor’s Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered.
- Prior experience preparing/authoring CMC DS sections:
- BLA highly preferred.
- Post-approval supplements/variations highly preferred.
- INDs/IMPDs.
- Prior development or manufacturing experience is a plus.
- 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.
- Excellent interpersonal skills to communicate difficult concepts.
- Strategic thinking and strong problem-solving skills
- Collaborates and communicates in an open, clear, complete, timely, and consistent manner
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
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.