We are looking for a Senior Regulatory Affairs Associate to join our Regulatory Affairs & Technical Writing team. In this role, you will be responsible for coordinating Global Clinical Trial applications for new and established medical products and devices, ensuring compliance with the latest ICH and regulatory guidelines. You will ensure timely submission of documentation while keeping clients, operational teams, and Regulatory Senior Management informed about all project aspects.

About the Company

Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage extensive therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We provide full-service clinical development solutions for small and mid-size drug developers, led by a centralized leadership team. Our focus on tailored and scalable solutions helps clients achieve their clinical and commercial objectives, as we share the same goal: to improve patients' lives.

Responsibilities

• Act as the Regulatory Lead for designated complex global and early phase clinical trials.
• Prepare, review, and submit clinical trial applications to Regulatory Authorities, Ethics Committees, and other necessary regulatory bodies.
• Assist in producing investigator brochures, protocols, IMPDs, and other supporting regulatory documentation.
• Prepare Patient Information and Consent Documents along with other patient-facing documentation.
• Support the Regulatory Affairs department in maintaining awareness and compliance with current local, national, regional, and harmonized guidance and requirements for regulatory and ethics procedures and submissions.
• Assist Project Managers with month-end financial reporting on their projects.
• Supervise and mentor less experienced Regulatory Affairs team members.
• Perform other duties as assigned by the Regulatory Affairs & Technical Writing management team, such as developing and writing SOPs and assisting in Business Development activities.

Requirements

• Bachelor's degree in Science or a medical field or equivalent.
• Extensive experience in submitting clinical trial applications globally to relevant Regulatory Authorities and Ethics Committees.
• Deep understanding of ICH-GCP.
• In-depth experience with the EU Directive and National Requirements for clinical trials.
• Experience in project reporting and liaising with multiple stakeholders, including clients and internal operational teams.
• Excellent command of the English language (written and oral) and local language where applicable.
• Strong analytical, planning, investigative, and problem-solving skills.

Nice to Have

• Advanced degree (Masters, PhD) or equivalent.
• Experience in Clinical Trial submission management of international clinical studies.
• Extensive experience working with regulatory agencies.
• Understanding of pharmaceutical/drug manufacturing regarding development, manufacturing, and quality.
• Fluency in another European language.