Position SummaryThe Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.
Essential Functions- Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
- Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
- Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
- Assist with developing and evaluating regulatory strategy
- Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
- Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.
- Performs other special projects and duties as requested.
Education & Experience- Bachelor's Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or
- 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
- Experience with US and International Health Authority regulatory submissions preferred
Knowledge, Skills, & Abilities- Knowledge of FDA, ICH and other guidance documents and requirements
- Knowledge of organizing responses to Regulatory Authority requests
- Strong knowledge of Health Authority regulatory requirements/guidelines
- Strong project management and computer skills (including Microsoft office)
- Strong document management experience (hard and e-copy)
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Strong organizational skills, written/oral communication skills and attention to detail
- Ability to manage conflicting priorities and respond in a timely, effective manner
Working Environment / Physical Environment- This is a full-time position (40 hours per week) Monday through Friday.
- This role may need to sit for long periods of time and use various computer programs.
- This desk-based role involves the close study of scientific and regulatory documents.
- They will work closely with scientific colleagues throughout the day, often on a project team basis.
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
$135,000 (entry-level qualifications) to $150,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
