Senior Regulatory Affairs Documentation Specialist

Overview As Senior Regulatory Affairs Documentation Specialist, you act as a subject-matter expert ensuring clinical, nonclinical, and regulatory documents are clear, accurate, and ready for submission. You will support development programs, health authority interactions, and global regulatory submissions. You’ll lead quality improvements of documentation, templates, and standards while guiding internal teams and external consultants. This two-year Basel-area contract offers potential extension or conversion to permanent, with meaningful impact on regulatory success. Verantwortungsbereiche Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with ICH and health authority requirements Ensure documents are suitable for NDA, MAA, and IND submissions Collaborate with authors and cross-functional stakeholders to improve document quality Contribute to the development and implementation of templates, guidelines, standards, and best practices Manage collaboration with external documentation quality specialists, including work allocation, oversight, and timely outputs Coach and mentor external consultants and colleagues in documentation quality control Support due diligence activities when required Zentrale Anforderungen Swiss residency or citizenship; Swiss/EU permissions Master’s degree or equivalent; science-related discipline preferred ≥10 years in clinical/nonclinical QA, medical/regulatory writing, or editing of clinical/nonclinical documents Strong knowledge of regulatory documentation requirements and submission standards Understanding of experimental methods, research design, and statistical analysis Ability to analyze and interpret medical data from clinical trials Excellent attention to detail, accuracy, judgement, and quality orientation Ability to work independently, manage priorities, and meet tight timelines Excellent communication and interpersonal skills; able to work across functions and with external partners Fluency in English; additional European languages are an advantage strong communication collaboration across functions attention to detail regulatory documentation and submission standards ICH guidance NDA/MAA/IND documentation