Senior Regulatory Affairs Specialist, EU/RoW (RareDisease)

Travere Therapeutics; Rapperswil-Jona; Presencial; CHF 110 000 - 160 000; Tempo integral

Resumo da oferta

Travere Therapeutics in Switzerland is seeking a Senior Specialist, Regulatory Affairs (EU/RoW) to support regulatory leads with submissions, strategy, and interactions with authorities to advance orphan/rare disease programs. The role involves regional regulatory operations, SOP development, and driving regulatory projects with oversight.

The ideal candidate has a biology-related degree, 4+ years of regulatory experience, and strong ability to navigate ICH/EU guidelines, prepare CTAs/MAAs, and

Qualificações

• Bachelor’s degree in a biological science is required; advanced degree preferred.
• 4+ years regulatory affairs experience in pharma/biotech or government health agency.
• Knowledge of drug development process and ICH/EU guidelines.
• Experience drafting regulatory submissions (CTA, MAAs, Variations).
• Ability to independently assess regulatory issues and develop practical solutions.
• Strong interpersonal, communication, analytical, organizational skills.

Responsabilidades

• Supports regulatory leads in preparation, submission and maintenance of regulatory applications (CTA, amendments, annual reports).
• Assists in drafting high-quality responses to questions from regulatory agencies.
• Ensures submissions are complete, properly formatted and compliant with requirements and timelines.
• Coordinates regulatory project activities and tracks commitments.
• Collaborates with regulatory affairs counterparts to meet submission goals.
• Monitors evolving regulatory requirements and contributes to strategy and planning.

Conhecimentos

Regulatory strategy

Cross-functional collaboration

Communication skills

Project management

Attention to detail

Problem solving

Travel readiness

Formação académica

Bachelor’s or equivalent in biological science

Advanced degree preferred

Ferramentas

Veeva Vault

Descrição da oferta de emprego

Travere Therapeutics in Switzerland is seeking a Senior Specialist, Regulatory Affairs (EU/RoW) to support regulatory leads with submissions, strategy, and interactions with authorities to advance orphan/rare disease programs. The role involves regional regulatory operations, SOP development, and driving regulatory projects with oversight.

The ideal candidate has a biology-related degree, 4+ years of regulatory experience, and strong ability to navigate ICH/EU guidelines, prepare CTAs/MAAs, and