International Regulatory Affairs Coordinator

4 weeks ago

Centennial, United States EUROFINS VRL INC. Full time

Company Description Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing. In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff. Eurofins stands for a conception of clinical diagnostics entirely focused on excellence, innovation and technological investment. Eurofins clinical diagnostics offers testing services in all medical specialties. As a central element in healthcare, clinical diagnostics contributes to every stage of patient care: predisposition, prevention, diagnostics, treatment monitoring and prognosis. With hundreds of thousands of clinical diagnostics tests performed every day, the laboratories of the clinical diagnostics division strive to ensure that every patient, wherever he or she lives, has access to the most specialized and most innovative techniques for diagnosis, monitoring and therapeutic adjustment. Our logistics expertise and our daily sample collection and delivery network, guarantee perfect continuity in the provision of care while ensuring the same standard of quality and access to innovation across all the regions we serve. Job Description International Regulatory Affairs Coordinator responsibilities include, but are not limited to, the following: Under the direction of the Director of Regulatory Affairs and Quality Assurance, this position will assist with the design, implementation and maintenance of International Standards and Regulations into the Eurofins DPT Quality Management System (QMS). Facilitate in the registration, licensing, accreditation, certification and/or application processes of current and new International Regulatory Bodies (e.g. Australian Therapeutic Goods Administration (TGA), German Health Authority (GHA)). Maintain and utilize working knowledge of current Good Manufacturing Practices (cGMP) and how current TGA and GHA Regulations, policies and expectations relate to Eurofins DPT's GMP compliance. Identify applicable international Regulatory or QMS related changes, that may have an impact to the organization and escalate the issue/incident appropriately. Promote and ensure international regulatory inspection readiness activities. Provide training and other learning opportunities to inter and intra-departmental employees related to the GMP Regulations and expectations of applicable international bodies. Represent Eurofins DPT in lead or supporting role (e.g., host) for international regulatory-based audits/inspections. Provide external auditors with requested information, ensure documentation is complete and accurate, and collaborate with operational staff for tours and interviews. Coordinate with the Audit Program owner to implement the Quality Audit schedule and assign auditors as necessary to meet the scope and expectations of the schedule. Perform quality audits in auditor or lead auditor role. Serve as a consultant for internal and external customers; assist RA/QA management in addressing business needs in international regulatory area by guiding identification of cause, finding best solution, supporting implementation and monitoring. Develop or revise standard operating procedures and/or policies, as applicable, to ensure applicable international regulatory requirements are incorporated into the QMS. Assist with non-internati nal regulatory activities and objectives when warranted. Perform duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions. In order to meet Eurofins DPT's quality policy and goals/objectives, all employees are expected to meet basic expectations of Eurofins DPT's quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping. Exhibit support of Eurofins DPT's business philosophy, leadership values, quality objectives, ethical behaviors, customer care and confidentiality standards at all times. Foster a positive work environment, modeling professional behavior. Pursue and actively participate in professional growth and development opportunities as they relate to and benefit the position and organization. Other duties as assigned, when necessary. Qualifications Basic Minimum Educational Requirements: Bachelor's degree (Life Science preferred) Basic Minimum Requirements: Minimum 5-10 years of quality, laboratory and/or regulatory experience in a regulated industry Minimum 3-5 years of experience in compliance with GMP regulations and expectations; experience with international regulatory and/or accrediting agencies preferred; Australian TGA experience highly desired. Ability to work effectively under the expectations of GMP and Quality Management System expectations

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