federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA...
, mentor, and grow a cohesive team. Knowledge of quality by design concepts and Regulatory (e.g. FDA and EMA) requirements...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
Responsibilities: Execute CSV activities in accordance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g...
two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10...
and European EMA, including ICH regulations Experience authoring, reviewing, and approving validation documentation High level...
., FDA, EMA, ICH-GCP). Ability to explain complex contract terms clearly and concisely Leadership skills to guide...
and application of global regulatory guidance (e.g., FDA, EMA, PMDA, etc.) that are essential in designing drug development strategy...
-graduate qualification Qualified Person Experience working for a regulatory organization such as FDA or EMA...
An understanding of FDA and EMA regulatory standards A familiarity with process control methodologies and control valves...