Associate Director, Regulatory CMC

Foster City, California
Sep 25, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Description 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.
Key Duties and Responsibilities
    • 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

Knowledge and Skills
    • Excellent interpersonal skills to communicate difficult concepts and persuade others
    • 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

Education and Experience
    • Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field
    • Typically requires 8 years of experience in the vaccine or biotech industry or in a related field, or the equivalent combination of education and experience.

Reports to: VP of Regulatory Affairs
Location: Foster City, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.