Regulatory Manager, Intelligence Services

A Career with Purpose

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world’s leading pharma and biotech companies.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success.

If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.

We are seeking a strategic and detail-oriented Regulatory Intelligence (RI) Manager to join the Regulatory Intelligence function at Bionical Emas. This role focuses on Early Access Programs (EAPs), including expanded access, compassionate use, named-patient supply, and other pre-approval access mechanisms. The RI Manager is responsible for monitoring, analyzing, and communicating global regulatory developments and policies that impact access to unlicensed medicines.

This position plays a pivotal role in maintaining the company’s world‑class regulatory intelligence database, ensuring that regulatory content and processes are consistently robust, current, and actionable. The insights generated will directly support timely and compliant access to medicines across diverse international markets, providing detailed and operationally relevant intelligence that enables cross‑functional teams to navigate complex regulatory landscapes with confidence.

The RI Manager will play a key role in ensuring the integrity, usability, and continuous improvement of regulatory intelligence systems and processes. This includes managing data inputs, maintaining high standards of accuracy, and contributing to system enhancements that align with evolving needs. The role will also be responsible for delivery of client projects.

• Act as a subject matter expert on global regulatory frameworks for expanded access, compassionate use, and pre‑approval access pathways
• Maintain and update the regulatory intelligence database ensuring accuracy, compliance, and relevance
• Liaise with global health authorities to obtain regulatory clarification, drafting strategic inquiries for targeted responses
• Lead structured regulatory surveillance to track global regulatory changes and share timely updates with internal teams
• Translate complex regulatory updates into actionable insights to support decision‑making across departments
• Develop and present regulatory intelligence reports and dashboards tailored for senior leadership and cross‑functional teams
• Manage and maintain country‑level regulatory data across internal systems, ensuring clarity, consistency, and version control
• Collaborate with internal stakeholders to refine regulatory processes and integrate local insights into the intelligence database
• Utilize AI and digital tools to enhance regulatory intelligence capabilities and system efficiency
• Support regulatory‑focused client projects by delivering high‑quality intelligence summaries and liaising directly with clients

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced regulatory qualification preferred
• Previous experience in regulatory affairs or intelligence within biotech, pharma, CRO is essential
• Hands‑on experience with Early Access / Expanded Access / Compassionate Use / Named‑Patient / Post‑Trial Access programs
• Strong regulatory intelligence skills, including monitoring, interpreting, and communicating global regulatory update
• Confident client‑facing communicator, able to explain complex regulatory concepts, manage stakeholders, and represent the business externally
• Highly organised, detail‑driven, and able to work independently as a proactive self‑starter
• Excellent written and verbal communication skills in English; additional languages are a plus
• Experience…