Regulatory Affairs Director
- Expired: over a month ago. Applications are no longer accepted.
Regulatory Affairs Director
Workforce Genetics is recruiting for a Regulatory Affairs Director for a clinical-stage T cell-focused biotech company dedicated to the discovery and development of novel immuno-therapeutics. Our client is focused on expanding the therapeutic horizon in Immuno-Oncology and Infectious Diseases by greatly reducing the fatality and morbidity of life-threatening and debilitating diseases.
The Regulatory Affairs Director ensures that all non-clinical and clinical development programs 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 stakeholders any updates to regulations. This position will also be responsible for developing the non-clinical/clinical regulatory strategy for 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 the company.
• Develops regulatory strategies for individual programs in nonclinical/clinical development towards the goal of successful registration 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
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