Supporting preparation, critical review, coordination, and submission of regulatory documents, including clinical trial applications, marketing authorisation applications, amendments, variations, supplements, responses to health authority questions, and lifecycle submissions * Providing regulatory input to cross-functional teams to support compliant development plans, clinical trial designs, submission documents, labelling considerations, and lifecycle activities * Coordinating with internal functions, affiliates, external partners, vendors, , and alliance stakeholders to support timely and compliant delivery of regulatory activities * Experience supporting clinical development, marketing authorisation applications, lifecycle management, and post-authorisation regulatory activities - We all know each other personally, work together and support each other - we are a team!
mehr