Regulatory Affairs Manager, EAP

Overview

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 Regulatory 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 as required through provision of regulatory expertise
• Work closely with wider Bionical Emas 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

Qualifications

• Bachelor's degree in a healthcare/science-related subject
• Previous experience in regulatory affairs within the life science industry
• Experience within EAPs would be advantageous but not essential

Benefits

• 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

How to apply

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!

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

About Us

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 .

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.

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' 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.