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 an individual contributor with advanced knowledge acquired from several years of experience within regulatory affairs in a clinical development setting. You will work independently within a team where you will be tasked to prepare and/ or review regulatory documents to support clinical trial submissions as well as independently provide regulatory support for more complex projects across the clinical team.
What will your job look like?
Acts as a Regulatory Advisor on complex clinical trial projects or programs
Ability to administratively, technically, and scientifically review core scientific documentation and feedback for gap analysis to customers
Prepares and maintains core clinical trial dossiers in accordance with applicable regulatory requirements
Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, Investigator's Brochure, clinical trial justifications with minimum support of senior staff
May strategically plan and oversee global country submissions
Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical development clinical trials
Can provide support on regulatory business development opportunities
Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met within budget
Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or Bionical Emas)
Deliver regulatory training/presentations as required
Performs other tasks or assignments, as delegated by Regulatory management
What will you need to succeed?
Degree in life science-related discipline or professional equivalent
Previous experience substantial regulatory affairs experience within a clinical setting
Good understanding of the regulations (GCP, ICH, EMA, etc.), directives and guidance supporting clinical Research and Development
Demonstrates comprehensive regulatory/technical expertise
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
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
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