Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Provide regulatory support for Early Access Programs and ensure compliance.
- Company: Join Bionical Emas, a leader in bringing life-changing medicines to patients globally.
- 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: Bachelor’s degree in healthcare/science and experience in regulatory affairs.
- Other info: Diverse and inclusive culture with opportunities for professional growth.
The predicted salary is between 45000 - 55000 £ per year.
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.
About the Role
We are looking for a Reg Affairs Manager to deliver strategic and operational regulatory support and expertise to the Early Access Program (EAP) team and clients to ensure efficient and compliant set‑up, maintenance and close‑out of EAPs.
Responsibilities
- Provide strategic and operational regulatory expertise and support to the EAP division
- Be the client point of contact for regulatory activities for multiple EAPs and attend regular client calls to provide regulatory updates as required
- Develop Regulatory Strategy Reports at the start of each EAP
- Manage and track all regulatory activities relating to set‑up, maintenance and close‑out of a live EAP
- Develop key regulatory documents for cohort regulatory including medical writing where required
- Prepare, collate and submit regulatory packages for cohort regulatory submissions in line with local requirements
- Develop and maintain regulatory database of global EAP regulations and guidelines
- Develop and maintain EAP regulatory SOPs
- Support business development process through provision of regulatory expertise
- Work closely with wider Bionical Emas Regulatory department to share learnings and provide EAP expertise as required
- Develop own external regulatory network relating to EAP Regulatory Affairs for the purpose of thought leadership, regulatory intelligence and continuous professional development
Qualifications
- Bachelor’s degree in a healthcare/science‑related subject
- Previous experience in a regulatory affairs within the pharmaceutical medicine environment
- Experience within EAP would be advantageous
Benefits
- 25 days of vacation
- Vacation days purchasing scheme
- One 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
Equal Employment Opportunity
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 programmes, 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 HR@bionicalemas.com.
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’s 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.
Regulatory Manager, Early Access Programs (EAP) employer: Bionical Emas
Contact Detail:
Bionical Emas Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Manager, Early Access Programs (EAP)
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Bionical Emas or similar companies. A friendly chat can open doors and give you insights that might just help you land that Regulatory Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your regulatory knowledge and understanding of Early Access Programs. We want to see your passion for bringing life-changing medicines to patients, so be ready to share how your experience aligns with our mission.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It shows your enthusiasm and keeps you fresh in their minds as they make their decision.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of our team at Bionical Emas.
We think you need these skills to ace Regulatory Manager, Early Access Programs (EAP)
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Manager role. Highlight your relevant experience in regulatory affairs and Early Access Programs, as this will show us you’re a great fit for the team.
Showcase Your Passion: We love candidates who are genuinely excited about making a difference in patients' lives. Share your motivation for wanting to work in the EAP space and how you can contribute to our mission at Bionical Emas.
Be Clear and Concise: When writing your application, keep it straightforward. Use clear language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website: Don’t forget 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. 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 your regulatory affairs knowledge, especially related to Early Access Programs. Familiarise yourself with the latest guidelines and regulations that Bionical Emas might be working with, as this will show your commitment and expertise during the interview.
✨Prepare for Client Interaction Scenarios
Since you'll be the point of contact for clients, think about how you would handle various client scenarios. Prepare examples from your past experiences where you successfully managed client relationships or resolved issues, as this will demonstrate your communication skills and problem-solving abilities.
✨Showcase Your Team Spirit
Bionical Emas values a supportive culture, so be ready to discuss how you work within a team. Share specific examples of how you've collaborated with others in previous roles, particularly in regulatory settings, to highlight your ability to contribute positively to their team environment.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the company culture. Inquire about their current projects in Early Access Programs or how they support professional development. This not only shows your interest but also helps you gauge if the company aligns with your career goals.