Associate Director, Regulatory CMC

About the role

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

• 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
• Reports to: Executive Director, CMC Regulatory
• Location: San Carlos, CA / US Remote
• Work Arrangement: Remote

Benefits

Additional Information

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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at vaxcyte? Share your experience