Manager, Regulatory Intelligence

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 worlds 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 wed love to hear from you.

About the Role

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 companys 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.

What will your job look like

• 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

What will you need to succeed

• Bachelors 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 with Market Access clinical trial regulations and digital / AI-enabled regulatory tools is desirable

What will you get in return

We want you to do your best work! We care about our peoples well-being their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.

• 25 days of vacation
• Vacation days purchasing scheme
• 1 extra vacation day per each 3 years of service
• Discretionary Annual Bonus
• Sabbatical of 3 to 6 months (after 2 years of service)
• Free food and beverages at all offices
• Life Insurance
• Health Insurance and Employee Assistance Programme
• Employee Support Networks help us continue to build on our inclusive culture
• Flexible and hybrid work

Does this sound like you

It is time to apply and we cant wait to hear from you!

Even if you dont meet 100% of the requirements be confident in yourself and dont hesitate to apply!

PLEASE NOTE: We will be longlisting applications as soon as we receive them so please apply early to register your interest.

We Are Bionical Emas

We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds voices beliefs and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth and pregnancy-related conditions) gender identity or expression (including transgender status) sexual orientation marital status military service and veteran status physical or mental disability genetic information or any other characteristic protected by applicable federal state or local laws and ordinances. Bionical Emas management team is dedicated to this policy with respect to recruitment hiring placement promotion transfer training compensation benefits employee activities access to facilities and programs and general treatment during employment.

Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance please let us know by sending an email with your request to the recruitment team at .

We Are Bionical Emas where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together we make a difference by powering an inclusive future for all. Be you with us.

Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect use and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process where we may process your personal information our purposes for processing your personal information and the rights you can exercise over Bionical Emas use of your personal information. By applying for the above position you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emas applicable to your place of residence.

Powering the patient journey