Senior Regulatory Affairs Documentation Specialist (7103)

CTC Resourcing Solutions AG; Basel; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions AG client in Switzerland seeks a Senior Regulatory Affairs Documentation Specialist for a 2-year contract in the Basel area. The role focuses on ensuring submission-ready clinical, nonclinical, and regulatory documents across NDA/MAA/IND programs.

The ideal candidate has Swiss work permit, a Master’s degree in a science field, 10+ years in regulatory writing or QA, and strong data analysis and cross-functional collaboration skills, with fluent English and additional

Qualifikationen

• Requires Swiss working/residency permit.
• Master’s degree in a science-related discipline is preferred.
• At least 10 years in clinical/nonclinical QA, regulatory writing, or document quality review.
• Strong knowledge of regulatory documentation requirements and submission standards.
• Excellent attention to detail and ability to meet timelines.
• Fluency in English; other European languages are a plus.

Aufgaben

• Review clinical, regulatory, and nonclinical documents for clarity, accuracy, and compliance.
• Ensure documents are suitable for NDA, MAA, and IND submissions.
• Collaborate with authors and cross-functional teams to improve document quality.
• Contribute to templates, guidelines, and best practices for documentation.
• Coordinate with external documentation quality specialists to ensure timely delivery.

Kenntnisse

Regulatory documentation

Quality assurance

Regulatory writing

Cross-functional collaboration

English fluency

Ausbildung

Master’s degree in science

Jobbeschreibung

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