Head of Regulatory Affairs (Pharmaceutical, Remote, Europe)

Job summary

This role involves leading regulatory affairs for oncology trials, ensuring compliance and timely approvals while managing a high-performing team. The position is home-based in the UK, Sweden, Denmark, or Netherlands, requiring significant experience in regulatory affairs within the life sciences sector.

Qualifications

• Bachelor's degree in a life science field (e.g., Pharmacy, Biology, Chemistry) or equivalent.
• At least 10 years of experience in regulatory roles within the pharmaceutical industry, including 5 years in clinical trials.
• Leadership experience in Regulatory Affairs is essential.

Responsibilities

• Develop and execute regulatory strategies aligned with business objectives.
• Ensure full regulatory compliance and readiness for inspections.
• Manage the planning and submission of Clinical Trial Applications (CTAs) and informed consent forms in the EU/EEA and UK.
• Serve as the regulatory liaison for multi-continental projects and collaborate with various departments.
• Provide regulatory training to team members and maintain awareness of literature on cancer therapy and clinical trial conduct.

Skills

• Strong interpersonal skills and ability to build collaborative relationships.
• Detailed knowledge of ICH-GCP and EU/UK/EEA regulatory requirements.
• Proficient in Microsoft Office applications, particularly Word, PowerPoint, and Excel.
• Fluent in written and verbal English.

Education

• Minimum bachelor’s degree in a life science field or equivalent.

Tools

• Experience with electronic trial master files (eTMF) and regulatory submission systems.