ImmunityBio
Senior Specialist, Regulatory Affairs
Summit, NJ · Senior · Full-time
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About the role
- Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
- Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
- Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
Responsibilities
- Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
- Assist with developing and evaluating regulatory strategy
- Performs other special projects and duties as requested.
Requirements
- Bachelor's Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required
- Master's Degree in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development required.
- Knowledge and experience with organizing responses to Regulatory Authority requests required
- Knowledge of organizing responses to Regulatory Authority requests
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Bachelor's Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or
Skills
- Knowledge, Skills, & Abilities
- Strong project management and computer skills (including Microsoft office)
- Strong organizational skills, written/oral communication skills and attention to detail
Compensation
- The annual base pay range for this position is below.
Company info
- At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.
Visa & Work Authorization
- race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.