(Senior) Regulatory Affairs Associate - Advertising & Promotional Labeling (home or office based)
We are seeking an experienced Regulatory Affairs Associate or Senior Regulatory Affairs Associate to join our team! In this role you will be ensuring compliance with Health Authority drug promotion and promotional labeling regulations for assigned licensed products across Europe. This role combines deep regulatory expertise with consulting excellence to deliver high-quality services to our clients while advancing commercial success. You will review, approve, or reject promotional programming based on European regulations and guidance, ensuring adherence to established processes, SOPs, and work instructions.Working within Parexel's consulting framework, you will provide regulatory leadership while delivering projects that meet both client and Parexel quality expectations. The role can be full remote or office based.Key ResponsibilitiesReview advertising and promotional labeling materials; comment, improve, approve, or reject content based on company practice, policy, European law, and Health Authority regulationsCollaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize/mitigate Health Authorities enforcement risk while advancing commercial objectivesMonitor and apply trends in regulation of advertising and promotional labeling to review practices and processesProvide regulatory leadership and guidance to marketing teams during development, review, and approval of promotional materials for assigned therapeutic areasPrepare and submit advertising and promotional labeling materials to Health Authorities as requiredServe as Project Lead for small-scale projects or Work Stream Lead on larger projectsSkills And Experience Required For The RoleUniversity in a Scientific or Technical DisciplineInitial years in Regulatory Affairs relevant industry experience in Advertising & Promotional Labeling (required)Ability to implement regulatory science and monitor enforcement trendsCapability to read and comprehend product-related technical and medical informationClient-focused approach with results orientationExcellent teamwork and collaboration skillsStrong consulting skills with critical thinking and problem-solving abilitiesProficiency in English written and spoken