As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Essential Job Duties: ·Oversight and accountability for RA/IRB/EC/Third Body submissions, including submission strategy, timeline planning, and delivering to the agreed upon timelines by tracking submission/approval timelines against projected milestones within relevant systems ·Provides consolidated country requirements and regular status updates to project team and Client, as applicable ·Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests by preparing, reviewing and providing input to core study documents as applicable. This may include the compilation, review and distribution of core package, QC of core package, and country packages, maintenance and close out ·Provide the highest quality advice on regulatory issues to members of project teams and its clients by maintaining awareness of current regulatory legislation, guidance and practice related to RA, IRB/EC and Third Body submissions ·Where applicable and if suitably experienced, provide guidance and regulatory expertise on the application of the EU CTR in CTIS to other stakeholders. Manage applicable user access to CTIS and act as a backup in case of unexpected absences of other team members ·Review and input into required Start Up project plans. Distribute, implement and monitor compliance to Start Up project plan with respect to RA/IRB/ EC/Third Body submissions ·Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables. Manage projects according to the billing guide to ensure the work is performed within budget. Notify the Start-Up Lead of hours identified as Out-of-Scope ·Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects. Support audits (internal and external) and inspections, as needed. Support resolution of any findings ·Present/attend at external and internal meetings including, but not limited to: project core team and client meetings, Pre-Post Award Transition (PPAT) and Time Expectations Meetings (TEM), Kick Off Meetings (KOM) ·Contribute to the development of the group through participating and leading in process improvement initiatives, e.g. developing and updating SOPs Requirements (Experience, Education, Qualifications and Skills) ·5-7 years' experience in the Pharmaceutical industry or Drug Development in Regulatory Affairs ·Excellent communication, organization and planning skills with an attention to detail ·Extensive experience in leading clinical trial applications at a regional/global level ·Direct project management skills and ability to work independently ·Existing experience as a Global Regulatory Submissions Lead (focus on Clinical Trial Applications) ·Experience in EU-CTR processes and with CTIS platform ·Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations in particular ·Bachelor's degree or higher ·Fluency in English Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
