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- Tasks: Lead regulatory intelligence efforts to ensure access to life-changing medicines globally.
- Company: Join Bionical Emas, a leader in Early Access Programs and Clinical Trial Supply.
- Benefits: Enjoy 25 days of vacation, health insurance, and flexible work options.
- Why this job: Make a real impact on patient lives while developing your career in a supportive environment.
- Qualifications: Degree in life sciences and experience in regulatory affairs or intelligence required.
- Other info: Diverse and inclusive culture with opportunities for personal growth.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
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?
- 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 updates
- 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?
- 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
It is time to apply, and we can't wait to hear from you! Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply!
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.
Regulatory Manager, Intelligence Services in London employer: Bionical Emas
Contact Detail:
Bionical Emas Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager, Intelligence Services in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Bionical Emas and understanding their values and culture. Tailor your responses to show how your skills align with their mission of bringing life-changing medicines to patients.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience in regulatory affairs and how it relates to Early Access Programs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Manager, Intelligence Services in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Manager role. Highlight your experience with Early Access Programs and regulatory intelligence, as this will show us you understand what we're looking for.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills align with the job description. Use specific examples from your past experiences that relate to regulatory affairs and client communication.
Be Clear and Concise: When writing your application, keep it straightforward. We appreciate clarity, so avoid jargon and make sure your points are easy to understand. This will help us see your thought process clearly.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role as soon as possible!
How to prepare for a job interview at Bionical Emas
✨Know Your Regulatory Stuff
Make sure you brush up on global regulatory frameworks, especially around Early Access Programs. Being able to discuss these topics confidently will show that you're not just familiar with the basics but can also navigate complex regulations.
✨Showcase Your Analytical Skills
Prepare to demonstrate how you've monitored and interpreted regulatory changes in your previous roles. Bring examples of how your insights have influenced decision-making or improved processes, as this will highlight your strategic thinking.
✨Communicate Clearly
Practice explaining complex regulatory concepts in simple terms. You might be asked to present information to non-experts, so being able to break it down will be key. Think about how you can make your communication engaging and relatable.
✨Be Proactive and Organised
Show that you're a self-starter by discussing how you manage your workload and keep track of regulatory updates. Bring a few examples of how you've improved processes or systems in your past roles to illustrate your proactive nature.