RA Manager

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

Gamida Cell is looking for a skilled and motivated Regulatory Affairs (RA) Manager to join Gamida Cell’s Regulatory Affairs Development team.

Job Title:  RA Manager
Location: Onsite in Israel

Roles and Responsibilities

  • Critical review of development reports, pre-clinical and clinical protocols and reports which are part of regulatory submissions
  • Summarize, compile and review of documents to prepare regulatory submissions and dossiers
  • Manage preparation of submission files, including coordination of input and review by different functional teams and consolidation of their feedback, maintaining high quality and adherence to timelines
  • Manage questions and answers received from Regulatory Authorities including updating labeling
  • Participate into cross-functional meetings to prepare for commercialization (supply chain, labeling) and provide input from a Regulatory perspective
  • Review and write controlled documents and SOPs related to regulatory activities

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in a Life Sciences related field (Biology/Biotechnology/Medical Sciences) or B.Pharm
  • Minimum 8 years of global RA experience in pharmaceutical/biopharmaceutical industry, including nonclinical, clinical and labeling aspects
  • Experience with managing of global registration of new investigational products
  • Experience with various submissions to FDA, EMA and local EU authorities
  • Understanding and knowledge of FDA and EMA regulatory guidelines for human drugs
  • Good scientific understanding and deduction capabilities
  • Basic knowledge of GMP and GCP principles
  • Technical and regulatory writing skills
  • Excellent verbal and written communication skills in English
  • Meticulous and paying attention to details
  • Good knowledge in Microsoft Office
  • Team player, strong analytical skills and ability to work with a minimal supervision, under pressure and meet deadlines
  • Good personal communication and interaction capabilities
  • Advantage: MSc degree in biology/biotechnology, experience and knowledge in cell therapy, experience with submissions in Japan

Reports to RA Senior Director

To apply: Send resume and cover letter to careers@gamida-cell.com

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