Senior Regulatory Affairs Manager

Rockville, MD - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

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: Masters degree in Regulatory Affairs

Experience:

Thirty Six (36) months 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

Required Experience:

Manager

Our CompanyNeoImmuneTech 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 executi...