Submission-Ready Regulatory Docs Lead – Clinical & Nonclinical

CTC Resourcing Solutions; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a Senior Regulatory Affairs Documentation Specialist for a 2-year contract in the Basel area of Switzerland. The role requires acting as a subject matter expert for the quality of clinical, nonclinical, and regulatory documentation and enabling submission-ready documents for multiple regulatory submissions.

Responsibilities include reviewing documents for accuracy and compliance, collaborating with authors and cross-functional teams, and developing

Qualifikationen

• Master’s degree or equivalent qualification; science-related discipline preferred.
• 7–10 years of relevant experience in clinical/nonclinical QA, medical or regulatory writing, or editing of clinical documents.
• Strong knowledge of regulatory documentation requirements, guidelines, submission standards, and document quality expectations.
• Fluency in English; additional European languages are an advantage.

Aufgaben

• Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures and health authority requirements.
• Ensure documents are suitable for inclusion in NDA, MAA, CSR, DSUR, and IND dossiers.
• Partner with authors and cross-functional stakeholders to improve the quality of documents.
• Develop and implement documentation templates, guidelines, standards, and best practices.
• Manage collaboration with external documentation quality specialists and oversee timely delivery.
• Coach and mentor external consultants and colleagues in documentation quality control.
• Support due diligence activities when required.

Jobbeschreibung

CTC Resourcing Solutions is seeking a Senior Regulatory Affairs Documentation Specialist for a 2-year contract in the Basel area of Switzerland. The role requires acting as a subject matter expert for the quality of clinical, nonclinical, and regulatory documentation and enabling submission-ready documents for multiple regulatory submissions.

Responsibilities include reviewing documents for accuracy and compliance, collaborating with authors and cross-functional teams, and developing