Regulatory Affairs Specialist, Cell

3 weeks ago

Philadelphia, United States Piper Companies Full time
Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.

Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy
  • Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders.
  • Oversee external publishing coordination for IND/CTA submissions and related documents.
  • Support document workflows for major submissions and health authority meetings.
  • Maintain regulatory systems, including trackers, SharePoint sites, and file sharing tools.
Qualifications of the Regulatory Affairs Specialist, Cell & Gene Therapy
  • 3+ years of pharmaceutical/biotech industry experience, with 2+ years of regulatory affairs/regulatory operations experience supporting pre-IND and IND stage regulatory submissions to the FDA
  • Maintains active IND and Clinical Trial applications.
  • Experience submitted to the Center for Biologics Evaluation and Research (CBER), preferably through the Office of Tissues and Advanced Therapies (OTP) for cell or gene therapy products.
  • Experience in early Phase 1 products within the fields of hematology/oncology or autoimmune diseases is desirable.
  • Proven expertise in managing regulatory submission workflows, collaborating with various stakeholders, and interpreting FDA requirements as well as current cell and gene therapy regulations in key markets like the US and EU.
  • Specific regulatory experience in the following regions and indications is highly preferred:
    • US FDA - Cell and Gene Therapy
    • Europe - Oncology
    • Australia - Autoimmune Diseases
    • China - Any of the above
  • Bachelor of Science degree in a life-science or related field is required.
Compensation for the Regulatory Affairs Specialist, Cell & Gene Therapy
  • Salary Range : $40.00 - $55.00 / hour
  • Benefits : Medical, Dental, Vision, 401k match, Paid Holidays, and PTO


Keywords: reg affairs, regulatory, regulatory affairs, early development, phase I, regulatory operations, pre-IND, IND submissions, Investigational New Drug, CBER, Center for Biologics Evaluation and Research, OTP, Office of Tissues and Advanced Therapies, cell therapy, gene therapy, EU, europe, US, FDA, federal drug administration, early phase, hematology, oncology, autoimmune disease, autoimmunology, CTAs, small molecule, biologics, drug products, pharma, pharmaceutical, biotech, biotechnology, regulatory strategy, CTA dossier, content plans, publishing, publish, annual reports, annual report, safety reports, protocol amendments, document workflow, major submissions, health authority meetings, vendor, SharePoint, MasterControl, CMC regulatory, literature reference, document management, PleaseReview

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