Senior Regulatory Affairs Specialist — Rare Disease

Travere Therapeutics; Schweiz; Remote; CHF 120,000 - 180,000; Full time

Job summary

Travere Therapeutics in Switzerland is hiring a Senior Specialist, Regulatory Affairs (EU/RoW) to support the preparation, submission and maintenance of regulatory applications, including CTA submissions and post-authorization activities.

You will work with regulatory leads, coordinate with external contractors, maintain document management systems such as Veeva Vault, and help implement process improvements across Regulatory Affairs.

Qualifications

• Bachelor’s Degree/Science in a biological science is required.
• 4+ years regulatory affairs experience in pharma/biotech or government health agency.
• Good knowledge of the drug development process.
• Experience in ICH and EU guidelines for product development and submissions.
• Experience drafting regulatory submissions (CTA, MAAs, Variations).
• Independent, proactive, able to work in a biotech environment.

Responsibilities

• Supports regulatory leads in preparation, submission and maintenance of regulatory applications (CTA, amendments, annual reports).
• Prepares high-quality responses to questions from regulatory agencies.
• Ensures submissions are complete, properly formatted and compliant with requirements.
• Interacts with regulatory authorities and coordinates with external contractors.
• Maintains document management and archival systems.

Skills

Regulatory affairs

CTA submissions

EU regulations

Documentation

Cross-functional teamwork

Veeva Vault

Education

Bachelor's in biological science

Advanced degree preferred

Tools

Veeva Vault

Job description

Travere Therapeutics in Switzerland is hiring a Senior Specialist, Regulatory Affairs (EU/RoW) to support the preparation, submission and maintenance of regulatory applications, including CTA submissions and post-authorization activities.

You will work with regulatory leads, coordinate with external contractors, maintain document management systems such as Veeva Vault, and help implement process improvements across Regulatory Affairs.