Description

Senior Regulatory Affairs Documentation Specialist – 7103

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for an experienced Senior Regulatory Affairs Documentation Specialist to act as a subject matter expert for the quality of clinical, nonclinical, and regulatory documentation.

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

This is a 2 years’ contract based in Basel area with high possibility of extension(s) or turning 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.
• Partner with authors, contributors, and cross-functional stakeholders to continuously improve 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, including work allocation, quality oversight, and timely delivery of outputs.
• Coach and mentor external consultants and colleagues developing expertise in documentation quality control.
• Support due diligence activities when required.

Qualifications and Experience:

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• Master’s degree or equivalent qualification required; a science-related discipline is preferred.
• 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 analyse 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 an advantage