Regulatory Affairs Associate, EAP

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 worlds 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 wed love to hear from you.

About the Role

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 daytoday 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 setup maintenance and closeout of EAPs as assigned by the Regulatory Lead

• Participates in internal and external programspecific calls as assigned by the Regulatory Lead and documents relevant regulatory updates and deliverables for escalation and followup

• 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

• Bachelors 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

We want you to do your best work! We care about our peoples 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 cant wait to hear from you!

Even if you dont meet 100% of the requirements be confident in yourself and dont 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 .

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