Regulatory Affairs Consultant – Swiss & Global Submissions

Parexel; Schweiz; À distance; CHF 120 000 - 180 000; Plein temps

Résumé du poste

Parexel is seeking an experienced Regulatory Affairs Consultant to join our global team in Switzerland. You will develop, review, and manage regulatory submissions and compliance activities for pharmaceutical products from clinical development through post-market activities.

You will collaborate with cross-functional teams, coordinate Swiss submissions, maintain SmPC/PIL labeling in local languages, and support the Head of Regulatory Affairs Switzerland in strategic regulatory planning.

Qualifications

• University degree in Life Sciences or related discipline.
• 5-8+ years of regulatory affairs experience with marketing authorization applications and post-approval variations.
• Strong knowledge of Swissmedic regulations.
• CTD/eCTD submissions experience; familiarity with Swiss labeling procedures.

Responsabilités

• Develop, contribute to, and review content for regulatory submissions according to Swiss guidelines across the product lifecycle.
• Coordinate major submissions, PSURs, CMC variations, and post-approval commitments.
• Collaborate with the Swiss regulatory team and cross-functional project teams to implement regulatory strategy.
• Maintain Swiss labeling (SmPC, PIL, artwork, packaging) in local languages.
• Support the Head of Regulatory Affairs Switzerland in regulatory activities.

Connaissances

Regulatory Affairs

CTD/eCTD submissions

Swissmedic regulations

German language

French language

English language

Formation

University degree in Life Sciences or related discipline

Description du poste

Parexel is seeking an experienced Regulatory Affairs Consultant to join our global team in Switzerland. You will develop, review, and manage regulatory submissions and compliance activities for pharmaceutical products from clinical development through post-market activities.

You will collaborate with cross-functional teams, coordinate Swiss submissions, maintain SmPC/PIL labeling in local languages, and support the Head of Regulatory Affairs Switzerland in strategic regulatory planning.