Senior Swiss Regulatory Affairs Consultant Basel

Parexel; Basel; Híbrido; CHF 120.000 - 170.000; Jornada completa

Descripción de la vacante

Parexel International seeks an experienced Regulatory Affairs Consultant to join our global Regulatory Affairs team in Basel, working from the office 2 days a week. You will develop, review, and manage regulatory submissions and compliance across product lifecycles, collaborating with cross-functional teams and applying independent judgment.

The role entails Swiss submissions per Swissmedic guidelines, CTD/eCTD builds, labeling in local languages, and lifecycle management.

Formación

• University degree in Life Sciences or related discipline.
• 5–8+ years of professional Regulatory Affairs experience (MAA and post-approval variations).
• Strong knowledge of Swissmedic regulations (mandatory).
• Experience preparing major regulatory submissions and variation packages to Swissmedic.
• Strong CTD and eCTD submission experience.
• Experience in biologics and vaccines development preferred.
• Knowledge of Rare Diseases, Autoimmune Diseases, or Oncology preferred.
• Fluent spoken and written German, French and English.

Responsabilidades

• Develop, contribute to, and review content and format for regulatory submissions for Swiss/Global programs.
• Coordinate regulatory submission aspects and maintain Swiss labeling in local languages.
• Collaborate with Swiss and Global Regulatory teams and cross-functional project teams.
• Support the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate.

Conocimientos

Regulatory affairs

CTD/eCTD knowledge

Swissmedic regulations

Cross-functional collaboration

Educación

University Degree in Life Sciences or related discipline

Herramientas

eCTD submission tools

Descripción del empleo

Parexel International seeks an experienced Regulatory Affairs Consultant to join our global Regulatory Affairs team in Basel, working from the office 2 days a week. You will develop, review, and manage regulatory submissions and compliance across product lifecycles, collaborating with cross-functional teams and applying independent judgment.

The role entails Swiss submissions per Swissmedic guidelines, CTD/eCTD builds, labeling in local languages, and lifecycle management.