**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. Purpose of the Mission : The CMC regulatory manager is involved in the company’s world-wide post approval regulatory activities related to Chemistry, Manufacturing and Controls (CMC) for biological products. Primary Tasks & Responsibilities Prepares submission strategy and planning for post approval CMC activities (Variations, renewals, market expansions, annual reports). Assesses the change controls and provides regulatory assessments regarding the classifications of quality changes in production and quality control Reviews study reports (process validation, stability studies, analytical method validation…), provided by quality control and production department to ensure compliance to regulatory requirements. Ensures the coordination of submission preparation with the departments involved: manufacturing, supply chain, quality control and quality assurance, but also other regulatory departments and local companies. Writes and or reviews submission content to ensure alignment with regulatory requirements (variations, questions from health authorities). Manages the projects within all Regulatory Information Management systems (maintenance of the worldwide submissions). Identifies, escalates and mitigates risks related to Regulatory procedures and activities Experience, Knowledge & Soft Skill Requirements Knowledge/skills: Exhibits a very good understanding of CMC and post approval regulatory requirements. Knowledge of regulatory procedures / systems / guidances (quality control, stability, process validation, comparability studies) Excellent level of spoken and written English Good level of spoken and written local language (depending on the location French, Italian or German) Knowledge of biological processes. Knowledge of Qualification / Validation principles. Soft skills: Manages own time to meet agreed milestones Good communication skills, able to work in multi-cultural and multi-disciplinary environment Writing skills Analytical skills, with an eye for detail Creative and critical mind Team spirit, flexibility and accountability, and well organized Experience Experience in regulatory affairs (related to technical/CMC/quality), in the pharmaceutical industry Experience in writing CMC (technical) parts of regulatory documents (registration files or variations). Experience working in validation/Quality Assurance/production in the Pharmaceutical industry, with experience of preparing regulatory documentation Education, Methodology & Certification Requirements University level (Life Sciences background is preferred) or equivalent by experience. Word, PowerPoint, Excel, experience with Veeva Vault is valued. Language Proficiency Requirements · English Fluent · French, German or Italian Depending on location Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.