Senior Regulatory Specialist - 100% ONSITE

Published: 6/14/2022

Job Description

We are seeking an experienced Senior Regulatory Specialist to lead the lifecycle of our clinical research protocols. This is a high-level, dedicated regulatory role for a subject matter expert who excels in IRB oversight and FDA compliance; please note this is a senior position requiring direct regulatory experience, not a transition role for CRCs or CRAs.

The Impact You’ll Make as a Senior Regulatory Specialist

Protocol Leadership: Manage the full submission process, including initial applications, continuations, and complex amendments to the IRB and study sponsors.
Compliance Excellence: Ensure all research correspondence and informed consent forms strictly adhere to FDA Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and institutional policies.
Document Mastery: Maintain meticulous regulatory files, including FDA Forms, Delegation of Authority, lab certifications, and Serious Adverse Event (SAE) submissions.
Strategic Liaison: Act as the primary point of contact between investigators, sponsors, and regulatory bodies to ensure seamless study progression.

Requirements for a Senior Regulatory Specialist

Education: Bachelor’s degree required.
Experience: 3+ years of dedicated experience as a Regulatory Coordinator or Specialist in clinical research (required).
Regulatory Knowledge: Deep working knowledge of IRB policies, Contracts and Grants procedures, and FDA regulations.
Technical Skill: Proven ability to draft professional research correspondence and manage complex regulatory documents (CVs, medical licenses, etc.).

Preferred Qualifications for a Senior Regulatory Specialist

1+ years of experience in Oncology research.
CCRP certification.
Proficiency with Epic software.