Regulatory Affairs Associate, 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.

We are looking for a Regulatory Affairs Associate to deliver strategic and operational regulatory support and expertise to the Regulatory team and clients to ensure efficient and compliant set‑up, maintenance and close‑out of Early Access programs.

What will your job look like?

• Manages day‑to‑day regulatory affairs activities to ensure adherence to all regulatory obligations and responses, including monitoring and actioning the Regulatory Inbox, portal request regulatory review process and required translations.
• Supports the development and ongoing maintenance of Regulatory Strategy Reports, trackers, and label text plans as assigned by the Regulatory Lead.
• Supports the creation and development of regulatory documents needed for program specific submissions as assigned by the Regulatory Lead.
• Creates new entries and maintains trackers that capture regulatory activities related to the set‑up, maintenance, and close‑out of EAPs, as assigned by the Regulatory Lead.
• Participates in internal and external program‑specific calls as assigned by the Regulatory Lead, and documents relevant regulatory updates and deliverables for escalation and follow‑up.
• Supports the development and maintenance of the regulatory database containing global regulations and guidelines, ensuring awareness of updates and actively sharing relevant knowledge with the wider team.
• Ensures all required training on departmental policies and SOPs is completed and maintained within established timeframes.

What will you need to succeed?

• Bachelor’s degree in a healthcare/science‑related subject.
• Previous experience in a regulatory affairs, or relevant related role within the pharmaceutical medicine environment, EAP would be preferable.
• Interest in career progression within Regulatory Affairs.
• Computer skills including proficiency in use of Microsoft Word, Excel and Powerpoint.
• Effective time management skills and ability to manage competing priorities.
• Excellent communication and interpersonal skills.
• High attention to detail.

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!

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.