Regulatory Operations Consultant

About the job

Our client, an innovative pharmaceutical company, is seeking a Regulatory Operations Consultant III to support its growing portfolio in Switzerland.

Regulatory Operations Consultant

Job description:

• Location: Basel
• Start Date: July 2026
• Duration: Until December 2026
• Workload: 100%

Requirements:

• Coordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs
• Support lifecycle management activities for marketed products, including product information updates and promotional material reviews
• Contribute to the development and implementation of regulatory strategies aligned with business objectives
• Collaborate closely with cross-functional teams to integrate regulatory requirements into development and lifecycle plans
• Support interactions with regulatory authorities, including preparation of briefing documents and meeting coordination
• Act as a local regulatory contact for Swissmedic and ensure submissions meet local requirements
• Manage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders
• Maintain regulatory documentation, submission tracking, and archiving within regulatory systems
• Conduct regulatory research and monitor changes in applicable regulations and guidelines
• Support commercial teams during product launches and throughout the product lifecycle by providing regulatory guidance

Competences:

• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline
• 3–5 years of experience within Regulatory Affairs in the pharmaceutical industry
• Experience interacting directly with Swissmedic
• Experience with Swiss marketing authorisation applications (MAAs)
• Familiarity with Swissmedic systems, including the Swissmedic Portal and national publication platform
• Solid understanding of drug development and the pharmaceutical regulatory environment
• Experience with lifecycle management and post-approval activities is an advantage
• Strong stakeholder management and cross-functional collaboration skills
• Fluent German and English, both written and spoken
• Strong organisational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment