Associate Director, Regulatory CMC

Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).

Prior experience preparing/authoring CMC DS sections:

Post-approval supplements/variations highly preferred.

Prior development or manufacturing experience is a plus.

Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).

Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines

The compensation package will be competitive and includes comprehensive benefits and an equity component.

$180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary.

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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.

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