Senior Associate Clinical Trials Regulatory Affairs

Location: Switzerland - Rotkreuz

Company

hirify.global is a global biotechnology company researching, manufacturing, and delivering medicines for patients worldwide.

What you will do

• Manage end-to-end clinical trial regulatory submissions in Switzerland for new and ongoing projects and programs.
• Prepare initial Swissmedic applications, protocol and informed consent amendments, quality amendments, periodic reports, and study closeout submissions.
• Act as the local hirify.global contact for Swissmedic and fulfill regulatory obligations in line with global standard operating procedures.
• Coordinate with clinical operations, global and international regulatory teams, CMC product leads, pharmacovigilance, vendors, and contracts teams.
• Maintain regulatory requirements databases and checklists, communicate regulatory status, and track submission milestones.
• Escalate regulatory issues and develop plans to address risks and gaps.

Requirements

• Bachelor’s or Master’s degree in natural sciences.
• Experience with regulatory submissions or study start-up, including technical knowledge of Clinical Trial Applications in Switzerland and Swissmedic processes.
• Clinical research experience gained at a biotechnology or pharmaceutical company or CRO.
• Excellent written and verbal English and fluent German are required.
• Ability to plan, develop, and manage regulatory timelines while handling multiple projects and priorities.
• Ability to work independently and asynchronously across time zones in a collaborative, matrixed environment.

Culture & Benefits

• Opportunities to learn and advance across a global organization.
• Diverse and inclusive community where employees are encouraged to contribute ideas and take action.
• Total Rewards Plan covering health, financial security, work-life balance, and career benefits.