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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 and development.
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. If you are inspired by changing the lives of patients all over the world, we’d 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 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?
We want you to do your best work! We care about our people’s 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 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!
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 HR@bionicalemas.com.
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.
Regulatory Manager, Intelligence Services employer: Bionical Emas
Contact Detail:
Bionical Emas Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager, Intelligence Services
✨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 your pitch! Be ready to explain your experience in regulatory affairs and how it relates to Early Access Programs. Keep it concise and impactful to grab their attention.
✨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
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 and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us see your potential quickly!
Apply Early!: We’re reviewing applications as they come in, so don’t wait! Head over to our website and submit your application as soon as you can. We can’t wait to hear from you!
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 the past. Bring examples of how your insights have influenced decision-making or improved processes in previous roles.
✨Communicate Clearly
Practice explaining complex regulatory concepts in simple terms. This is crucial for liaising with stakeholders and clients, so think about how you can convey your knowledge without jargon.
✨Be Proactive and Organised
Highlight your ability to work independently and manage multiple tasks. Share specific instances where your organisational skills led to successful project outcomes, especially in a regulatory context.