in compliance with relevant regulatory requirements (FDA, EMA, etc.). Support the preparation and review of regulatory...
with regulatory agencies including FDA and EMA. Prepare for and participate in key regulatory meetings including pre-IND, end... a supervisory role Strong understanding of regulatory requirements of FDA, EMA and ICH throughout the product development process...
, knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle Strong technical leadership...
or insight for commercial partner EMA designs during reviews and other activities. - Participate in anomaly and failure...
manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...
. Overview: Aba & Ema are hiring a DIVISIONAL TRAINING MANAGER! Lettuce Entertain You Restaurants is looking for a Divisional...
. Familiarity with pertinent regulations (FDA, EMA), standards, and guidelines, emphasizing quality, safety, and environmental...
development within various Therapeutic Areas Knowledge of FDA, or EMA, or other international regulations for prescribing...
of EU EMA pharmaceutical regulations and guidance is preferred Direct experience with IND/NDA filings is preferred...
of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions is preferred. Direct...