In addition to the submission dossier content, interactions with health authorities (HAs) before and after the marketing application submission are critical for an efficient and successful new drug approval. Briefing documents to support a pre-submission HA interaction require a clear presentation of the sponsor’s submission strategy, with focused questions accompanied by the sponsor’s position. During the submission review period, concise yet comprehensive responses to HA questions are needed to facilitate timely regulatory decision-making. Smooth progression through these phases of the submission journey requires medical writers to merge writing and project management skills with regulatory knowledge and strategic insight.