Regulatory Manager, Early Access Programs (EAP)

About the Role

We are looking for a Reg Affairs Manager to work 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 EAP’s.

What will your job look like?

• 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 as required through provision of regulatory expertise
• Work closely with wider [Employer hidden] Regulatory department to share learnings and to 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

What will you need to succeed?

• 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

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 [Employer hidden].

• 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

Application Instructions

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! PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest.

If you are interested in applying for employment with [Employer hidden] and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at [contact hidden].