A Career with PurposeBionical 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 RoleWe are looking for a Reg Affairs Manager to join our EAP global team. This individual willwork 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 divisionsBe the client point of contact for regulatory activities for multiple scopes and attend regular client calls to provide regulatory updates as requiredFormulate regulatory strategy reports and/ or regulatory plans at the start of each EAPManage and track all regulatory activities relating to set-up, maintenance and close-out of projectsDevelop key regulatory documents for regulatory and ethics submissionsPrepare, collate and submit packages for regulatory and ethics submissions in line with local requirementsContribute information of global regulations and guidelines to company's regulatory databaseDevelop and maintain regulatory SOPsSupport business development process as required through provision of regulatory expertiseWork closely with management team to develop the regulatory functionWork closely with wider Bionical Emas Regulatory department to share learnings and to provide Regulatory expertise as requiredWhat will you need to succeed?Bachelor's degree in a healthcare/science-related subjectPrevious experience in a regulatory affairs in a relevant pharma/CRO environmentProven ability to interpret and apply complex regulationsIn-depth knowledge of drug development process and pharmaceutical industry experienceKnowledge of GDP, PV and GCPExperience of regulatory dossiers compilations and submissionsWhat 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 vacationVacation days purchasing scheme1 extra vacation day per each 3 years of serviceDiscretionary Annual BonusSabbatical of 3 to 6 months (after 2 years of service)Free food and beverages at all officesLife InsuranceHealth Insurance and Employee Assistance ProgrammeEmployee Support Networks – help us continue to build on our inclusive cultureFlexible and hybrid workDoes 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 EmasWe 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#J-18808-Ljbffr
