Senior Specialist, Regulatory Affairs

ImmunityBio•Summit, NJ

13d•$135,000 - $150,000

About The Position

The 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.

Requirements

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
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

Nice To Haves

Experience with US and International Health Authority regulatory submissions preferred

Responsibilities

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.

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
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