Remote Regulatory Affairs Consultant - Swissmedic

Parexel; Basel; Remote; CHF 120,000 - 180,000; Full time

Job summary

Parexel is seeking an experienced Regulatory Affairs Consultant to join our global team in Basel, Switzerland. You will develop, review, and manage regulatory submissions and compliance activities across the product lifecycle, collaborating with cross-functional partners.

The ideal candidate has 5–8+ years in Regulatory Affairs, deep Swissmedic knowledge, CTD/eCTD experience, and fluent German, French and English.

Qualifications

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

Responsibilities

• Develop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines.
• Coordinate regulatory submission aspects relevant to assigned projects and programs.
• Maintain Swiss labeling (SmPC, PIL, artwork, and packaging in local languages).
• Collaborate with the Swiss regulatory team, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to develop and execute regulatory strategy throughout the product lifecycle.
• Demonstrate ability to work independently and with project teams to achieve goals.
• Support the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate.

Skills

German language

French language

English language

Regulatory submissions

CTD/eCTD submissions

Swissmedic regulations

Cross-functional collaboration

Labeling/SmPC knowledge

Education

University Degree in Life Sciences

Job description

Parexel is seeking an experienced Regulatory Affairs Consultant to join our global team in Basel, Switzerland. You will develop, review, and manage regulatory submissions and compliance activities across the product lifecycle, collaborating with cross-functional partners.

The ideal candidate has 5–8+ years in Regulatory Affairs, deep Swissmedic knowledge, CTD/eCTD experience, and fluent German, French and English.