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 have an opportunity for a Senior Regulatory Manager within the Clinical Development team.You will be a highly skilled and experienced regulatory expert, with recent hands-on experience of successful clinical trial submissions within the Latin America and/or Asia-Pacific regions.You will be an accomplished communicator, adept at conveying complex regulatory information in simple format.You will be driven and self-motivated able to prioritise your own workload and deliver projects to time-and-target.This is an exciting opportunity to join a growing Regulatory team contributing to the Bionical Emas vision of bringing life-changing medicines to patients around the world.Interested? Let's get in touch What will your job look like?Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone regulatory project,with guidance from senior staff as appropriate Develops and adheres to a regulatory submission plan, in consultation with Client representative(s) and internal stakeholders and in accordance with project timelines Performs and/or oversee global clinical trial regulatory and ethical applications and maintains and closes-out approvals; accountable for the delivery of regulatory and ethical submissions to time-and-target Competently writes regulatory and/or technical documents with minimal review by senior staff Establishes relationships with many customers; may meet face-to-face without rest of team to discuss regulatory issues and present lessons learned.Adopts a proactive and flexible approach to resolve any issues Undertakes detailed review and management of budgets related to projects, including out of scope activities.Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate May give guidance to colleagues, including feedback on the quality of technical documents, and may assist in their training and development May present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff May write new regulatory SOPs and regulatory intelligence databanks, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate Performs other tasks or assignments, as delegated by Regulatory management What will you need to succeed?Bachelor's or Master's degree in life science-related discipline or comparable years of experience in clinical research Extensive relevant experience of clinical trial regulatory ethical applications globally,including Latin America and/or Asia-Pacific regions Good understanding of the regulations directives and guidance supporting clinical Research and Development (GCP, ICH, EMA, etc.)Demonstrates comprehensive regulatory or technical expertise at a global level Ability to establish and maintain effective working relationships with co-workers, managers and clients 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 ****** .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 We look forward to hearing from you! #J-18808-Ljbffr
