Senior Specialist, Regulatory Affairs

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.
• Affiliate 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.

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 Skills

• 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.
• The 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.

Pay

The annual base pay range for this position is $135,000 (entry-level qualifications) to $150,000 (highly experienced) annually.

Benefits

• 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