EAP Regulatory Affairs Manager

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 Reg Affairs Manager to join our EAP global team. 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? Provide strategic and operational regulatory expertise and support to the EAP divisions Be the client point of contact for regulatory activities for multiple scopes and attend regular client calls to provide regulatory updates as required Formulate regulatory strategy reports and/ or regulatory plans at the start of each EAP Manage and track all regulatory activities relating to set-up, maintenance and close-out of projects Develop key regulatory documents for regulatory and ethics submissions Prepare, collate and submit packages for regulatory and ethics submissions in line with local requirements Contribute information of global regulations and guidelines to company’s regulatory database Develop and maintain regulatory SOPs Support business development process as required through provision of regulatory expertise Work closely with management team to develop the regulatory function Work closely with wider Bionical Emas Regulatory department to share learnings and to provide Regulatory expertise as required What will you need to succeed? Bachelor’s degree in a healthcare/science-related subject Previous experience in a regulatory affairs in a relevant pharma/CRO environment Proven ability to interpret and apply complex regulations In-depth knowledge of drug development process and pharmaceutical industry experience Knowledge of GDP, PV and GCP Experience of regulatory dossiers compilations and submissions 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