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Senior Regulatory Affairs Specialist
2 months ago
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.
You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We are looking for a Senior Reg Affairs Associate to join our EAP team on a fixed term contract basis. 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.
Manage day-to-day regulatory affairs activities to ensure compliance with regulatory obligations and requests
With support from a senior regulatory team member, be the client point of contact for regulatory activities for assigned Early Access Programs and attend regular client calls to provide regulatory updates, as required
Provide an initial assessment for feasibility reviews or regulatory questions as required, with support from a senior regulatory team member
Develop Regulatory Strategy Reports and/ or regulatory plans at the start of each project
Manage and maintain trackers of regulatory activities relating to set-up, maintenance and close-out of projects
Develop key regulatory documents for regulatory submissions, including performing regulatory review of protocols and Informed Consent Forms
Prepare, collate and submit packages for regulatory submissions in line with local requirements, with support from a senior regulatory team member
Support with the development and maintenance of the regulatory database of global regulations and guidelines
Work closely with wider Bionical Emas Regulatory department to share learnings and to provide Regulatory expertise as required
Develop own external regulatory network relating to Regulatory Affairs for the purpose of regulatory intelligence and continuous professional development
Perform and manage administration of regulatory release of shipments
Bachelor’s degree in a healthcare/science-related subject preferred
Previous experience in regulatory affairs field within the pharmaceutical or clinical research organization (CRO) environment
Previous experience within EAP or compassionate use would be advantageous
We care about our people’s well-being, their personal development and providing a true work-life balance. 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
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 sarah.We celebrate individuality while encouraging our talents to work as a team. 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. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: applicable to your place of residence.
