Regulatory CMC Specialist with MDR experience for Medical Device

Company Description Spark CMC Consulting Corp. provides Regulatory CMC authoring and strategy support to the pharmaceutical industry. The company assists in both pre-approval and post-approval submission activities. Our team is dedicated to ensuring that clients meet regulatory requirements efficiently and effectively. Spark CMC Consulting Corp. is committed to excellence in regulatory compliance and enhancing the quality of submissions. Role Description This is a part-time remote role for a Regulatory CMC Consultant for a short engagement (maximum 3 months). The consultant will be responsible for reviewing a MAA application and propose changes for a Type II variation to register an autoinjector (Medical device). Experience with authoring Module 3 CTD sections is a must. Additional tasks include providing strategic regulatory affairs support, regulatory intelligence search and managing specific regulatory projects. Qualifications Experience in Regulatory Requirements, and Regulatory Affairs (Chemistry, manufacturing and controls, CMC focused) Proficiency in preparing and managing Regulatory Submissions (Module 3 and Module 2.3) Working knowledge of regulatory submissions in European markets Strong organizations skills, excellent written and verbal communication skills Ability to work independently and remotely Bachelor's degree or higher in a relevant field or equivalent experience