Through the interpretation of regulations, you will provide regulatory strategy and advice for radiopharmaceutical projects. Additional responsibilities include assisting in FDA reviews by moderating meetings and coordinating the review of required documents for regulatory submissions while acting as a liaison between regulatory authorities and Berlex. Knowledge of regulatory guidelines such as GCP, GLP, GMP, and ICH is required. Excellent organizational, interpersonal and communication skills are essential. You should be able to prioritize to respond to critical issues and be a team player.
Some travel is required.
At Berlex, you ll also find competitive salaries and a generous benefits package. We are located in Northern New Jersey, just 30 minutes from New York City.