Regulatory Operations Consultant

Responsibilities

• 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...