statistical content of major early regulatory submissions, such as INDs, EMA scientific advice packages, and pre IND or end...
(FDA, EMA, NMPA, ICH M10, E6). Exceptional leadership and people management skills with a record of developing scientific...
with strong knowledge of cGMP/ICH/FDA/EMA regulations Expertise with analytical test method optimization, validation, and transfer as well...
Control environment. · Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the...
requirements and standards (FDA, EMA, MHRA, PMDA). Experience leading quality transformation initiatives that deliver regulatory...
are conducted in compliance with applicable cGMP, ICH, FDA, EMA, and global regulatory expectations for small-molecule development...
sciences investment banking background;experience with RWE/HEOR;knowledge of FDA/EMA regulatory pathways;prior work building...
agreements (EMA/NEMA) Navigate multi-stakeholder negotiations and procurement processes Achieve and exceed quarterly...
assessments)SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal...
therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA...