We bring breakthrough pioneering therapies to patient with life threatening diseases
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of CAR-T therapies. Our ambition is to develop a unique platform to offer new treatment options to cancer patients, addressing multiple targets, optimizing the signaling domain, and weaponizing the T-Cell.
Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
While Celyad is headquartered in Mont-Saint-Guibert, close to Brussels, the company is clinically active across Europe and the U.S and we constantly seek to showcase our Research & Development activities in the international area through publication and congress presentation. Consequently, Celyad offers a stimulating working environment with the opportunity to interact with colleagues and stakeholders across the globe involved at each step of the product development process.
At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
Great! Celyad is looking for an enthusiastic:
Regulatory Affairs Associate (M/F)
The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report into the Head of Regulatory Affairs (located in the US).
Role & Responsibilities
- Manage documentation of regulatory interactions in compliance all applicable regulatory requirements and organizational policies;
- Manage the preparation and submission of global regulatory applications and notifications for assigned projects;
- Establish and maintain Regulatory documentation (submission planning tools and trackers, archive correspondence, etc);
- Write and prepare well-organized and scientifically sound regulatory documents including eCTD-compliant regulatory submissions;
- Ensure adherence to applicable requirements, accuracy, consistency, completeness of regulatory documents, as needed to meet global business objectives;
- Support RA team in various activities, communications and documentation as needed, including research, writing, proof-reading, and QC review;
- Support Regulatory team meetings including agenda, minutes and logistics.
Qualifications & Experience
- A Master in Pharmaceutical Sciences, Life Sciences or equivalent with at least 2 years in pharmaceutical industry is required; a PhD is a plus
- Regulatory affairs experience is strongly preferred; experience in eCTD-compliant regulatory submissions is a plus;
- Experience of working within a quality management system (e.g. GMP, GCP, GLP) is strongly preferred;
- Knowledge of European, US and International laws, regulations and guidelines for pharmaceuticals, biologics, medical devices, human cells and tissues strongly preferred;
- Experience in Immuno-oncology and/or advanced therapy medicinal products is preferred.
Skills & Competencies
- Outstanding written and verbal communication skills, including excellent organization and attention to detail;
- Good team player, used to working in multifunctional environments;
- Ability to build and maintain excellent working relations at all levels with strong professional integrity;
- Ability to take initiative and work independently on assigned activities;
- Ability to manage complex projects and organize heavy workloads effectively;
- Flexibility to adapt to rapidly-evolving business needs in fast-paced environment
- Creative thinking
- Excellent computer literacy, Microsoft Office Suite applications strongly preferred
- Languages : Fluent English (written and spoken), additional languages are a plus
For more information about this position or about the Company, please contact us by email at email@example.com