Job Summary:We are seeking a highly skilled Regulatory Affairs - Assistant Manager (Europe Market) tojoin our team. The successful candidate will be responsible for ensuring compliance withregulatory requirements for our products, managing the submission process for regulatoryapprovals, and maintaining up-to-date knowledge of regulatory changes.Essential Duties and Responsibilities: Technical Expertise: Proven experience in preparing CEPs/ASMFs from Scratch,submitting, and maintaining ASMFs/DMFs and CEPs (initial submissions and variations)to the EDQM and/or European National Competent Authorities. Regulatory Compliance: Ensure company products comply with relevant regulatoryrequirements, and local regulations. Software: Familiarity with electronic submission systems and validation software likePharma ready, Lorenz. Document Preparation: Proven ability to independently prepare Modules I, II, and IIIof APIs and Excipient. Login/Account Creation: Having knowledge to make Company Login/Account Creationon all Countries Regulatory Portals. Regulatory Strategy: Develop and implement regulatory strategies to support productdevelopment and commercialization. Regulatory Intelligence: Stay up-to-date with changing regulatory requirements andprovide guidance to internal stakeholders. Audits and Inspections: Coordinate and manage regulatory audits and inspections. Regulatory Agency Interactions: Communicate with regulatory agencies, such as theEMA, EDQM, FDA, to address questions and concerns. Regulatory Documentation: Maintain and manage regulatory documents, such asregulatory submissions, approvals, and correspondence. Training and Guidance: Provide regulatory training and guidance to internalstakeholders. Compliance Monitoring: Monitor company activities for compliance with regulatoryrequirements. Advantage: It would be a significant asset to possess skills in preparing and submittingDMFs/Master Files/Submissions to regulatory bodies in regions including Europe/UK,Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, and Mexico.Skills : Must have good knowledge of Regulatory Submissions and Preparation. Must have good knowledge of Regulatory Research. Must be familiarity with chemical industry specific regulations and guidelines.