Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWorking at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!Reporting to the Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist independently leads regulatory activities for Yale Cancer Center Clinical Trials Office clinical research protocols from study activation through closeout while managing the study portfolio for assigned disease teams. The role provides regulatory leadership for complex, federally regulated investigator-initiated trials, overseeing study start-up, submissions, maintenance, and ongoing compliance with independence and sound judgement. This position interprets and applies federal regulations, Good Clinical Practice (GCP), and institutional policies to ensure regulatory compliance throughout the study lifecycle and serves as a key regulatory resource to investigators and research teams. The role works closely with management and the broader regulatory team to balance workload priorities, meet critical deadlines, ensure timely submissions, and monitor compliance. In addition, the Senior Regulatory Affairs Specialist mentors and provides guidance to Regulatory Affairs Specialists I and II, promotes best practices, and identifies opportunities to improve regulatory processes and operational efficiency in support of disease program and departmental objectives.Required Skills and Abilities:Demonstrated ability to interpret and apply extensive knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Proven ability to interpret high acuity clinical trial protocols and manage several studies concurrently while balancing competing priorities/deadlines.Professionalism, maturity, good judgment, works with confidential and proprietary material and protected health information. Superior interpersonal, communication and listening skills. Ability to work with individuals across the organization and external stakeholders. Team leader; mentors, teaches, coaches, delegates. Provides guidance, instruction, and critical feedback.Highly autonomous worker with extreme flexibility in work focus; able to switch among studies without adverse effects. Assignments are time intensive and highly complex. Decisions are guided by expertise, context, independent judgment and clear to obscure guidelines and policies and can impact the areas of which they are accountable.Ability to initiate planning, researching and management of high acuity clinical trials using superior understanding and expert knowledge of study start up activities and clinical research processes across the study lifespan. Works under minimal supervision. Understands when to inform others of developments or issues with a specific study.Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.Preferred Skills and Abilities:Advanced degree and certificate in related field. Experience in clinical research compliance, regulatory research, and/or operations in the academic or private sector. Experience in a Cancer Center setting. Two or more years of supervisory or mentoring experience in regulatory affairs.Preferred Licenses or Certifications:SOCRA/ACRP/RAPs (or equivalent) certification or ability to obtain within one year of employment.Principal Responsibilities:Serves as the primary specialist on regulatory affairs processes for all types of clinical research studies, including high acuity trials.Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. Provides critical input into modified workflows and policies to address changes.Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and responses at time of study initiation, execution/maintenance and close out. Interprets and applies regulations, policies and procedures to advise others on regulatory and compliance matters.Utilizes regulatory expertise and employs regulatory strategy to provide technical review of and draft required reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes.Facilitates communication between PI, study team and University key stakeholders to support regulatory activities for applicable studies.Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the essential documents for all trial types, including highly acuity clinical research trials.Identifies instances of noncompliance and deviations from the protocol and regulatory requirements. Oversees and prepares reports to the appropriate parties and committees.Analyzes regulatory activities program wide and identifies areas for improvement or that require correction. Provides recommendations and oversees implementation of recommendations, as needed.Collaborates directly with Investigators and leadership to prepare and execute corrective and preventative action plans and assist with quality reviews to ensure implementation and adherence to stated plan.Collaborates with the Quality Education Unit in the design and execution of Regulatory Specialist trainings and continuing education.Collaborates with regulatory team and management to prepare for and facilitate in interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies.Monitors, interprets, applies and communicates new and revised federal and state regulations, and local/institutional policies and guidance.Functions as a team lead; assesses workload accountability.Assists with Regulatory Affairs Specialist study transfer activities for training, documentation of training.Performs project oversight, promotes change management and manages workload challenges and delegation as requested.Partners with the CTO Quality and Education team to onboard, train, and mentor junior regulatory affairs staff.Performs other duties as assigned.Required Education and Experience:Bachelor's degree in life sciences or other health related discipline required and minimum of five (5) years' experience in regulatory affairs support.