.Regulatory Affairs Lifecycle Process Coordinator (Remote) Regulatory Affairs Lifecycle Process Coordinator | Adalvo | Portugal We are looking for an enthusiastic Regulatory Affairs Lifecycle Process Coordinator to join our dynamic Adalvo team. This position offers an opportunity for well-suited candidates to join a growing, fast-paced energetic environment and culture. SUMMARY OF POSITION The Regulatory Affairs Lifecycle Process Coordinator is responsible for ensuring compliance with applicable laws, regulations, and guidelines to facilitate the approval of all post-approval activities of products. ORGANIZATION STRUCTURE The role reports directly to the Director, Operational Regulatory Affairs and is located in Portugal. RESPONSIBILITIES Provide the highest quality advice on regulatory issues to team members by maintaining awareness of current regulatory legislation, guidance, and practice related to post-approval activities. Able to assess the technical complexities, scientific challenges, and regulatory landscape with full accountability to the end business requirements. Address complex and diverse challenges with decision-making that impacts launches/replenishment orders. Proactively engage in all post-approval activities to ensure project deliverables are met and to overcome regulatory enquiries. This includes quality check of submission packages by identifying, highlighting, and resolving issues where necessary. Initiate improvements to enhance the efficiency and quality of work performed by the lifecycle management team. Initiate, coordinate, and track variations, renewals, and MA transfers for the assigned medicinal products, approved through European procedures (MRP, DCP, CP) or national submissions across all regions of interest. Inform all involved departments on the status and progress of the assigned projects, so that objectives are met, any potential issues are identified, and solutions are being found. Compile, verify, and publish submissions using electronic publishing software considering the submission deadlines and technical requirements on management of dossiers lifecycle. Ensure stronger compliance on data and knowledge management. QUALIFICATIONS & REQUIREMENTS Solid regulatory affairs expertise and technical background in a similar position. Excellent communication and planning skills. Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple diverse projects simultaneously. Direct project management skills and ability to work independently. Resourceful, creative problem-solver with a positive attitude to analyze and offer solutions. English language: advanced level, both speaking and writing. Computer skills: very good knowledge of MS Office tools. Project management capabilities, including but not limited to creation of timelines, organization of meetings, meeting minutes, planning, and execution. Solution-oriented working skills
