Senior Regulatory Affairs Manager

Our Company

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and has a strong executive team with rich industry experience.

We Offer

• Competitive pay
• 401(k) company matching - 100% vests immediately!
• Medical insurance
• Flexible Spending Account (FSA)
• Life insurance
• Paid Time Off
• Paid holidays
• Paid family medical leave
• Cell phone reimbursement
• Internet reimbursement
  
  

Education: Master’s degree in Regulatory Affairs

Experience:

• Thirty Six (36) month’s experience with the following duties:
• Gather regulatory intelligence, assess regulatory risks, & evaluate pathways for approval & registration of new product with applicable agencies
• Develop regulatory strategies & implement plans for preparation & submission of new products Develop & manage regulatory timeline through nonclinical phase, clinical study phase, marketing/registration phase, and post-marketing phase
• Manage preparation of applications including submission packages, and respond to health authority questions/comments
• Review regulatory & company product documents to ensure compliance with regulatory requirements Maintain TMF
• Review CRO contracts (scope & budget), set milestones & supervise CRO work Create SOP for regulatory affairs division & align SOPs in related divisions
  
  

Special Skills or other Requirements:

• Preparation of CTD-Modules 2.4, 2.5, 2.6, 2.7, 4, & 5 Preparation of US-IND documents
• Preparation of US FDA meeting packages
• Preparation of EMA Scientific Advice meeting packages Use of eCTD publishing software
• Assessing local requirements to facilitate product registration.
  
  

NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

If you require assistance to complete a job application, please email us at hr-us@neoimmunetech.com.