Senior Regulatory Affairs Associate

TL;DR

Senior Regulatory Affairs Associate (Clinical Development): Coordinating global clinical trial applications for medical products and devices with an accent on regulatory compliance and ICH-GCP standards. Focus on managing complex submissions, mentoring team members, and ensuring timely documentation for regulatory authorities and ethics committees.

Location: Must be based in the UK, Belgium, Hungary, Italy, Netherlands, Poland, Serbia, or Spain

Company

hirify.global is a full-service CRO providing flexible, innovative clinical development solutions for small and mid-size drug developers.

What you will do

• Act as the Regulatory Lead for complex global and early-phase clinical trials.
• Prepare, review, and submit clinical trial applications to Regulatory Authorities and Ethics Committees.
• Produce investigator brochures, protocols, IMPDs, and patient-facing documentation.
• Maintain awareness and compliance with local, national, and regional regulatory guidance.
• Supervise and mentor less experienced team members.
• Assist with project financial reporting and business development activities.

Requirements

• Bachelor's degree in a Science or medical field.
• Extensive experience in submitting clinical trial applications globally.
• Deep understanding of ICH-GCP and EU Directives for clinical trials.
• Excellent command of English (written and oral).
• Experience in project reporting and stakeholder management.
• Strong analytical, planning, and problem-solving skills.

Nice to have

• Advanced degree (Masters, PhD).
• Experience in international clinical study submission management.
• Understanding of pharmaceutical drug manufacturing and quality.
• Fluency in an additional European language.

Culture & Benefits

• Permanent full-time position.
• Home-based work arrangement.
• Opportunity to work with a responsive and agile full-service CRO.
• Focus on innovative, high-quality solutions for clinical development.