Regulatory Manager, Early Access Programs (EAP) in London

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.

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 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.

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.