Snr Reg Affairs officer

RESPONSIBILITIES Develop high-quality Clinical trial content for Regulatory Intelligence including expert summary generation and cross-country tables. In-depth knowledge on clinical trial regulatory including:Requirements in all phases of drug development (phase I-IV studies)Clinical trial applications and ethics committeesRegulatory processes and approval timesKnowledge on clinical trial registries and results disclosed.Ability to assess impact of new regulatory requirements.Compassionate Use/Expanded Access programs Ability to assess and anticipate impact of new regulatory requirements on clinical trials. Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, complet