Regulatory Affairs Consultant – Germany & Austria (Munich on-site) m/f/d

About the RoleWe are seeking an experiencedRegulatory Affairs Professional to provide comprehensive regulatory support for Germany and Austria. This is a strategic role that combines deep regulatory expertise with business acumen, supporting our client's mRNA therapeutics and vaccines across Germany and Austria.This role requires at least one day per week on-site presence (the office is in Munich).Key ResponsibilitiesRegulatory Strategy & Guidance: Deliver forward-looking, pragmatic, and creative strategic regulatory guidance to affiliate and brand teams, anticipating regulatory challenges and providing agile solutionsRegulatory Compliance & Operations: Support local business objectives through coordination of cross-functional reviews, translations of product information, artwork management, and market implementation activitiesStakeholder Management: Review promotional materials and medical communications; provide regulatory training and updates to local affiliate teams; represent the Regulatory Affairs team in internal, affiliate, and cross-functional meetingsMarket Access Support: Coordinate regulatory activities related to pricing, reimbursement, and tender processesAuthority Relations: Manage and coordinate interactions with German and Austrian regulatory authorities concerning client\'s pipeline and licensed productsProject Leadership: Independently manage multiple complex regulatory projects in a fast-paced environment while maintaining precision, compliance, and strategic judgmentInnovation & Efficiency: Explore opportunities to leverage Generative AI and emerging digital capabilities to enhance regulatory intelligence, content workflows, and operational efficiencyLeadership Support: Deputise for the Director, Regulatory Affairs Strategy – Germany and Austria as neededRequired Skills and Qualifications:University Degree in a Scientific or Technical Discipline (Advanced Degree preferred)Extensive years of experiencein regulatory affairs and regulatory strategyDeep knowledge of German, Austrian, and European pharmaceutical regulations, including: innovative medicines and vaccines, drug development and marketing authorisation procedures, line extensions and lifecycle managementStrong working knowledge of regulatory systems and tools (artwork management systems, text-verification tools, electronic document/data management systems)Strategic thinking and sound regulatory judgmentCritical thinking and problem-solving expertiseClient-focused approach with consulting acumenFluent in German and English(written and verbal)#LI-REMOTE #J-18808-Ljbffr