Title: Senior Regulatory Affairs Manager: Remote Position with Sign on Bonus Potential
Company: Yale Cancer Center Clinical Trials Office
Reporting to the Regulatory Manager, the Senior Regulatory Affairs Specialist plays a key role in the research and treatment mission of Yale Cancer Center Clinical Trials Office (“CTO”) by managing the study portfolio and independently executing regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout. The Senior Regulatory Affairs Specialist will be aware of and take a leadership role in implementing changes due to updates to regulations and policies governing clinical research and planning for the regulatory aspects of growth to support the research enterprise. The Senior Regulatory Affairs Specialist is responsible for regulatory start-up of new protocols, including providing regulatory expertise in the development, preparation, submission, and management of complex federally regulated YCC Investigator-Initiated and multisite trials. This role will interface with faculty and department staff across the organization, as well as identify and define logistics, action items or information needed to maintain regulatory affairs support, as well as create and foster a collaborative, positive relationship with internal staff and external organizations. The Senior Regulatory Affairs Specialist oversees and makes decisions or commitments that require interpretation and analysis of federal research regulations, Good Clinical Practice and the institution's policies and procedures. The Senior Regulatory Affairs Specialist will monitor workload intensity and track deadlines within their disease team’s assigned portfolio and ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting key performance metrics for CTO leadership and departmental stakeholders. The Senior Regulatory Affairs Specialist collaborates closely with their team, management, and provides leadership and mentorship to Regulatory Affairs Specialists 1 and 2. This role identifies growth opportunities and further efficiencies that impact the disease program and/or department’s success. The Senior Regulatory Affairs Specialist interfaces with key stakeholders to maintain and further develop disease program growth, as well as relationship building and maintenance.
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SOCRA Exp: 5/1/2023