Head of Regulatory CMC
years in a leadership position. Comprehensive understanding of CMC regulations and guidelines, particularly FDA and EMA...
years in a leadership position. Comprehensive understanding of CMC regulations and guidelines, particularly FDA and EMA...
with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA). Experience with Python programing and Python data...
Ability to mentor and influence junior staff members Thorough knowledge of clinical research concepts, practices, and FDA/EMA...
, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity...
of regulatory requirements specific for nonclinical modules, ICH guidelines, FDA and EMA/CHMP regulations and guidelines...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
of regulatory submissions comply with FDA, EMA, ICH guidelines, and other relevant regulatory agency requirements. Collaborate... contact for CMC-related interactions with global regulatory agencies, including FDA, EMA, and other regulatory bodies. Lead...
. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
. Strong knowledge of FDA, MHRA or EMA regulations, as appropriate, and ICH GCP guidelines. Excellent verbal and written communication...