Sr. Manager, Regulatory Affairs
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AI Summary
Develop and execute global regulatory CMC strategies for investigational products and lead the preparation of regulatory submissions. Manage interactions with Health Authorities and provide regulatory guidance to cross-functional teams to ensure global compliance.
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
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 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.
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.
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