Senior Regulatory Affairs Associate EAP - Maternity Cover

A Career with Purpose

Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world. We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.

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 Senior Reg Affairs Associate to join our EAP team on a fixed term contract basis. This individual will work 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 projects.

What will your job look like?

• Manage day-to-day regulatory affairs activities to ensure compliance with regulatory obligations and requests
• With support from a senior regulatory team member, be the client point of contact for regulatory activities for assigned Early Access Programs and attend regular client calls to provide regulatory updates, as required
• Provide an initial assessment for feasibility reviews or regulatory questions as required, with support from a senior regulatory team member
• Develop Regulatory Strategy Reports and/ or regulatory plans at the start of each project
• Manage and maintain trackers of regulatory activities relating to set-up, maintenance and close-out of projects
• Develop key regulatory documents for regulatory submissions, including performing regulatory review of protocols and Informed Consent Forms
• Prepare, collate and submit packages for regulatory submissions in line with local requirements, with support from a senior regulatory team member
• Support with the development and maintenance of the regulatory database of global regulations and guidelines
• Work closely with wider Bionical Emas Regulatory department to share learnings and to provide Regulatory expertise as required
• Develop own external regulatory network relating to Regulatory Affairs for the purpose of regulatory intelligence and continuous professional development
• Perform and manage administration of regulatory release of shipments

What will you need to succeed?

• Bachelor’s degree in a healthcare/science-related subject preferred
• Previous experience in regulatory affairs field within the pharmaceutical or clinical research organization (CRO) environment
• Previous experience within EAP or compassionate use 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 Bionical Emas.

• 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

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.

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 HR@bionicalemas.com.

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.

Powering the patient journey