Senior Regulatory Affairs Specialist Job New Haven area,Connecticut USA,Pharmaceutical

Working 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!

Overview

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…