Senior Regulatory Affairs Specialist

Department: Comprehensive Cancer Center - Clinical Trial Operations 221 Whitney Ave, reputed company, Connecticut reputed company: 137305WD $82,000.00 - $131,500.00 reputed company Working at reputed company means contributing to a reputed company reputed company. Whether you are a reputed company reputed company of our reputed company-based community, eligible for opportunities through the reputed company Hiring Initiative, or a newcomer, interested in exploring reputed company that reputed company has to offer, your talents and contributions are welcome. Discover your opportunities at reputed company! reputed company Reporting to the Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist independently leads regulatory activities for reputed company Cancer Center reputed company Office clinical research protocols from study activation through closeout while managing the study portfolio for assigned disease teams. The role provides regulatory leadership for reputed company, federally regulated investigator-initiated trials, overseeing study start-up, submissions, maintenance, and ongoing compliance with independence and reputed company judgement. This position interprets and applies federal regulations, Good Clinical reputed company (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 reputed company submissions, and monitor compliance. In reputed company, 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 1. Demonstrated ability to interpret and apply extensive knowledge of Food and Drug Administration (FDA) regulations, Good Clinical reputed company (GCP) guidelines, and other applicable federal regulations. Proven ability to interpret high reputed company clinical trial protocols and manage several studies concurrently while balancing competing priorities/deadlines. 2. 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 reputed company stakeholders. Team leader; mentors, teaches, coaches, delegates. Provides guidance, instruction, and critical feedback. 3. Highly autonomous worker with extreme flexibility in work reputed company; reputed company to reputed company among studies without adverse effects. Assignments are time intensive and highly reputed company. reputed company are guided by expertise, context, independent judgment and reputed company to obscure guidelines and policies and can reputed company the areas of which they are accountable. 4. Ability to initiate planning, researching and management of high reputed company reputed company using superior understanding and expert knowledge of study start up activities and clinical research processes across the study reputed company. Works under reputed company supervision. Understands reputed company to inform others of developments or issues with a specific study. 5. Proficiency in reputed company Office Suite (Word, reputed company, reputed company, etc.); Internet skills. Preferred Skills and Abilities Advanced degree and certificate in reputed company field. Experience in clinical research compliance, regulatory research, and/or operations in the reputed company 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 reputed company one year of employment. reputed company Responsibilities • Serves as the reputed company specialist on regulatory affairs processes for reputed company types of clinical research studies, including high reputed company trials. • Maintains knowledge of changing regulations and policies governing clinical research and assesses the reputed company of such changes on the regulatory affairs department. Provides critical input into modified workflows and policies to address changes. • Manages, implements, and evaluates reputed company aspects of regulatory activities and strategies including submissions and responses at time of study initiation, execution/maintenance and reputed company out. Interprets and applies regulations, policies and procedures to advise others on regulatory and compliance reputed company. • Utilizes regulatory expertise and employs regulatory reputed company to reputed company technical review of and draft required reports and makes recommendations based on analysis of the protocol and knowledge of reputed company, 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 reputed company trial types, including highly reputed company 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 reputed company plans and assist with reputed company reviews to ensure implementation and adherence to stated plan. • Collaborates with the reputed company 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 reputed company, internal audits and reputed company audits/inspections for highly reputed company clinical research studies. • Monitors, interprets, applies and communicates new and revised federal and state regulations, and local/institutional policies and guidance. • Functions as reputed company reputed company; assesses workload accountability. • Assists with Regulatory Affairs Specialist study transfer activities for training, documentation of training. • Performs project reputed company, promotes change management and manages workload challenges and delegation as requested. • Partners with the CTO reputed company and Education team to reputed company, 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 reputed company discipline required and minimum of five (5) years’ experience in regulatory affairs support. reputed company Date 08/10/2026 Job Category reputed company Bargaining Unit NON Compensation Grade Administration & Operations Compensation Grade Profile Manager; Program Leader (25) Salary reputed company $82,000.00 - $131,500.00 Time Type Full time Duration Type Staff Work Model Remote Background reputed company Requirements reputed company candidates for employment will be subject to reputed company-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position reputed company and job requirements. reputed company offers are contingent upon the successful completion of the background reputed company. For additional information on the background reputed company requirements and process visit "Learn about background checks" under the Applicant Support Resources reputed company of Careers on the It's Your reputed company website. Health Requirements Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy. Posting Disclaimer Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and reputed company reputed company market conditions. The reputed company of this reputed company is to reputed company a representative reputed company of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-reputed company duties through their hiring department. The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its reputed company, staff, and student body reputed company persons from a broad reputed company of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, reputed company does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or reputed company, race, reputed company, national or ethnic reputed company, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran. Inquiries concerning reputed company's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). Note reputed company is a tobacco-free reputed company. Apply tot his job Apply To this Job