Senior Regulatory Affairs Specialist (CMC)

Strong professional experience in pharmaceutical industry in preparing and maintaining regulatory documentation for different markets,Good knowledge of Regulatory Affairs CMC principles and pharmaceutical quality concepts,Scientific education, g. a scientific (technical), university degree (e.g. pharmacy, chemistry, food chemistry, biology, life science, pharmaceutical management),Understanding of international regulatory requirements (e.g. ICH, EU, FDA),Very good English skills,Organizational and communication skills,Very good knowledge of Microsoft Office. Your future companyFor our client, leading pharmaceutical organization with strong market presence, we are currently looking for a person to join the global regulatory affairs team. Hired person will be responsible for the preparation, maintenance and life cycle management of CMC (Chemistry, Manufacturing, and Controls) information within regulatory dossiers for pharmaceutical products, food supplements and cosmetics. The offer Attractive salary package including annual bonus, Broad benefits package, Opportunity to learn and grow in a positive and supportive team of professionals, Working in global team in friendly work atmosphere, Professional trainings. ,[Prepare, write, and maintain high‑quality CMC sections in regulatory dossiers (CTD Module 2.3, Module 3, and technical files) for marketing authorization applications and lifecycle submissions., Develop, update, and manage CMC documentation for: Initial marketing authorization submissions, post‑approval changes (variations), Lifecycle management activities (LCM)., Assess quality change control activities impacting the product portfolio and update or prepare required CMC documentation for regulatory review., Gather, request, and verify technical data and documentation from cross‑functional teams across the organization., Prepare and coordinate responses to CMC‑related Deficiency Letters from Health Authorities., Act as the main CMC contact for internal and external stakeholders, including development, manufacturing, quality, and external partners., Represent the CMC area in cross‑functional projects, contribute to regulatory initiatives, and lead CMC‑related topics., Support regulatory activities through close collaboration with the RA department., Define and recommend CMC regulatory strategies for new and existing products, including quality assessments., Ensure compliance with global regulatory requirements and guidelines (e.g., ICH, EU, FDA)., Support onboarding of new team members and help build team expertise., Perform peer reviews within the CMC team and suggest improvements or solutions where needed., Contribute to improving CMC documentation processes and regulatory standards.] Requirements: Pharmaceutical industry, Regulatory Affairs CMC, ICH, EU, FDA, Organizational skills, Communication skills, MS Office