The job, in the employer's words
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.
Benefits mentioned
- 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.
Requirements mentioned
- 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.
- Reports to: Executive Director, Regulatory CMC
- Location: US - Remote
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