Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance...
of Moh’s) a plus, not required EMA, Athena, and/or ModMed experience strongly preferred Current Basic Life Support (BLS...
) guidelines, FDA, and EMA regulations. Oversee safety monitoring and data integrity across trials, ensuring patient safety... relationships with regulatory agencies, including FDA and EMA, and oversee submissions (e.g., INDs, NDAs, BLAs) to ensure timely...
regulatory requirements (e.g. 21 CFR Parts 4, 11, 210, 211, 820, EMA, WHO, etc). Acting as resource for inquiries. Serving...
, mentor, and grow a cohesive team. Knowledge of quality by design concepts and Regulatory (e.g. FDA and EMA) requirements...
is required. Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired...
., FDA, EMA, ICH-GCP). Ability to explain complex contract terms clearly and concisely Leadership skills to guide...
, mentor, and grow a cohesive team. Knowledge of quality by design concepts and Regulatory (e.g. FDA and EMA) requirements...
An understanding of FDA and EMA regulatory standards A familiarity with process control methodologies and control valves...
two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10...