Associate Director, Regulatory CMC
$180,000–$210,500 year
RemoteUnited States or California, United States
Job Summary
Develop and execute multi-product global regulatory CMC strategies for investigational products, leading the preparation and filing of regulatory CMC submissions. Manage interactions with Health Authorities for CMC topics and provide regulatory CMC guidance to cross-functional teams while ensuring all applicable global regulatory requirements are incorporated into product development. Conduct routine regulatory surveillance, communicate new regulations, and lead the review of CMC sections in global submissions including BLAs, post-approval supplements, and INDs/IMPDs. Define CMC content requirements for regulatory submissions and manage regulatory assessments on change controls, deviations, and GMP investigations. Represent the company in Health Authority meetings and act as the primary regulatory CMC contact for assigned projects. Stay abreast of evolving FDA, EMA, and ICH guidelines, applying this knowledge to assigned projects and sharing insights with the team.
Required Qualifications
- Bachelor's Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices)
- Minimum 10 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
- Post-approval supplements/variations
- INDs/IMPDs
- Prior development or manufacturing experience
- Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines
Desired Qualifications
- 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
- BLA highly preferred
- Post-approval supplements/variations highly preferred
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