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Regulatory Affairs Director
Founded in 2014 and based in Rockville, MD, NeoImmuneTech (NIT) is a clinical-stage T cell-focused biotech company dedicated to the discovery and development of novel immuno-therapeutics. At NIT, we strive to expand the therapeutic horizon in Immuno-Oncology and Infectious Diseases by greatly reducing the fatality and morbidity of life-threatening and debilitating diseases. Led by our scientific founder, who invented our lead asset NT-I7 (efineptakin alfa), we are science driven and patient focused. We believe that with NT-I7, the only clinical stage IL-7, we can enhance the body’s immune function to address key resistance mechanisms in Immuno-Oncology and deadly infectious diseases. We have a profound belief, rooted in our science, that we have the power to transform patient care with unique assets like NT-I7, and are committed to the pursuit of discovering their full potential in treating various diseases.
- Remote and hybrid work opportunities
- Competitive pay
- Annual promotion opportunities
- 401(k) + company matching – 100% vests immediately!
- Free medical insurance
- Flexible Spending Account (FSA)
- Free life insurance
- Paid time off
- Paid holidays
- Paid sick leave
- Paid Family Medical Leave
- Free lunches, snacks, and drinks
- Cell phone reimbursement
- Internet reimbursement
The Regulatory Affairs Director ensures that all non-clinical and clinical development programs at NIT meet relevant guidelines, standards, and regulations. This position will be working with both the Translational Research Division and Clinical Division as well as with the partner CROs directly to ensure compliance and inform NIT of any updates to regulations. This position will also be responsible for developing the non-clinical/clinical regulatory strategy for NIT’s target markets such as US, EU, and LATAM in accordance with each country’s regulatory requirements to enhance the probability of regulatory success and regulatory compliance and being the main liaison with regulatory agencies as a representative of NIT.
- Develops regulatory strategies for individual programs in nonclinical/clinical development towards the goal of successful registration in NIT’s target markets such as US, EU, and LATAM
- Provides non-clinical/clinical regulatory guidance and updates to the relevant division(s)
- Manages CROs in preparing regulatory documents for submission including:
- CTD-Modules 2.4, 2.5, 2.6, 2.7, 4, and 5 regulatory writing and/or review
- US-IND documents
- EU-CTA documents (e.g., IMPD-nonclinical/clinical part)
- USFDA Formal meeting package (e.g., meeting request form, meeting package on nonclinical/clinical questions, company positions, and meeting minutes
- EMA Scientific Advice meeting package (e.g., letter of intent, briefing documents on non-clinical/clinical questions and company positions)
- Compiles and maintains appropriate regulatory documents for submission
- Provides regulatory approvability assessments for the relevant indications
- Manages timelines for non-clinical/clinical documents’ deliverables and regulatory submissions
- Leads regular internal and CRO meetings for status and tracking updates, issue resolution, project monitoring, and escalating issues to key stakeholders
- Ensures that all non-clinical and clinical programs and data are compliant
- Leads communication with regulatory authorities regarding meetings and submissions including orphan drug designation, IND filing/amendment, CTA filing/amendment, USFDA formal meeting, EU-NCA SA meeting, EMA-SA meeting, annual report, drug safety update report, etc.
- Prepares and supports efforts for pre-approval of GCP Inspection from regulatory authorities
- Responsible for life cycle management in all concerned countries
- Provides leadership and guidance to team members including coaching and performance evaluations
- Bachelor’s degree in a life science required; Master’s degree or PhD preferred
- 12+ years of experience in clinical development, clinical operations, and/or regulatory affairs
- Related experience working in oncology or immuno-oncology therapeutics
- Experience interacting directly with FDA
- Experience leading, managing, and preparing CTD & eCTD regulatory submissions
- Working knowledge of ICH, GCP, and FDA and EMA guidelines/regulations
- Understands the drug development process with a special emphasis on regulatory requirements at each development stage for nonclinical and clinical at EMA as well as USFDA
- Approximately 30% travel may be required (not applicable during the COVID-19 pandemic)
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.
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Job posted: 2022-08-04