with multiple agencies (FDA, EMA, JNDA, TGA). Leadership: Support Cell Culture CMC teams, and align resources to deliver...
supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA...
of management experience leading technical teams Expert knowledge of cGMP requirements and regulatory standards (FDA, EMA...
in new facility start-up or tech transfer projects Expertise in global regulatory requirements (FDA, EMA...
required In-depth understanding of GMP manufacturing Broad knowledge of US and international regulations and standards (FDA, EMA...
systems meet regulatory and validation requirements (e.g., 21 CFR Part 11, EMA Annex 11) Support GxP Computer System...
, Coder) and their integrations preferred. In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP. Strong expertise...
, Coder) and their integrations preferred. In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP. Strong expertise...
mitigation and data quality strategies. In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP. Strong expertise...
mitigation and data quality strategies. In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP. Strong expertise...