Quality Assurance Specialist
, cell & gene therapy, etc.). Basic understanding of cGMP principles and regulatory requirements (FDA, EMA...
, cell & gene therapy, etc.). Basic understanding of cGMP principles and regulatory requirements (FDA, EMA...
, cell & gene therapy, etc.). Basic understanding of cGMP principles and regulatory requirements (FDA, EMA...
to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START...
, quality, FDA and EMA regulations, technical transfer, process development and validation. Skilled in improving productivity...
Study Reports (CSRs), publications of clinical research findings and presentations to relevant FDA, EMA, or other Health...
therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA...
leadership. Lead and oversee global Health Authority engagement strategies, including FDA, EMA, and other international.... Proven experience interacting with global Health Authorities (e.g., FDA, EMA) at a senior level. Experience negotiating...
, and applicable industry standards. In-depth knowledge of FDA, EMA, and global regulatory requirements and their interface...
regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA...
Laboratory Practices. Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product...