Senior Regulatory Affairs Documentation Specialist / Senior Regulatory Affairs Documentation Specialistess

Senior Regulatory Affairs Documentation Specialist – 7103

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, is committed to delivering products to the market across multiple therapeutic areas over the next five years. They are seeking an experienced Senior Regulatory Affairs Documentation Specialist to serve as a subject matter expert in the quality of clinical, nonclinical, and regulatory documentation.

This role ensures that key deliverables are clear, accurate, consistent, compliant, and submission-ready, supporting development programs, health authority interactions, and global regulatory submissions.

This is a two-year contract based in the Basel area, with a strong possibility of extensions or transitioning into a permanent role.

Main Responsibilities:

• Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures, templates, ICH guidance, and relevant health authority requirements.
• Ensure documents are suitable for inclusion in critical regulatory submissions, including NDA, MAA, and IND dossiers.
• Collaborate with authors, contributors, and cross-functional stakeholders to continuously enhance the quality of clinical and regulatory documents.
• Contribute to the development and implementation of documentation templates, guidelines, standards, and best practices.
• Manage collaboration with external documentation quality specialists, overseeing work allocation, quality assurance, and timely output delivery.
• Coach and mentor external consultants and colleagues in developing expertise in documentation quality control.
• Support due diligence activities as required.

Qualifications and Experience:

• Relevant Swiss working/residency permit and/or Swiss/EU citizenship required.
• Master’s degree or equivalent qualification, preferably in a science-related discipline.
• At least 10 years of relevant experience in clinical and/or nonclinical quality assurance, medical or regulatory writing, or the editing and quality review of clinical and nonclinical documents.
• Strong knowledge of regulatory documentation requirements, guidelines, submission standards, and document quality expectations.
• Good understanding of experimental methods, research design, and statistical analysis.
• Ability to analyze and interpret medical data generated in clinical trials.
• Excellent attention to detail, accuracy, judgement, and quality orientation.
• Ability to work independently, manage priorities, and deliver effectively within tight timelines.
• Excellent communication and interpersonal skills, with confidence working across functions and with external partners.
• Fluency in English; additional European languages are an advantage.

Apply online using the form below. Only applications matching the job profile will be considered.