Senior Regulatory Docs Lead – Global Submissions

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

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