Senior Executive, Regulatory Affairs

Compiles, prepares, and reviews ANDA submissions and Amendments to FDA to avoid major deficiencies and obtain approval within shortest timeframes. Maintains full awareness of regulatory activities on assigned projects and ensures project deadlines and performance standards are met.

Requirements

• 5-7 years of Regulatory Affairs CMC experience handling Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms
• Experience with Aseptic sterilization or Terminal sterilization or both techniques
• Good problem-solving skills and analytical ability
• Strong computer skills and ability to learn new programs quickly