Job Description

Regulatory Affairs Specialist

Full Time - 40 hours a week

ONSITE - Springfield, MA, US

Summary: The Regulatory Affairs Specialist (Level 2) independently manages regulatory submissions, communications, and documentation across multiple studies at clinical research sites. This mid-level position requires an in-depth understanding of FDA, ICH-GCP, HIPAA and IRB requirements as well as proficiency in regulatory software tools and CTMS.

• Prepares and submits regulatory documents to IRBs and sponsors independently.
• Maintains regulatory binders electronically and in the CTMS in compliance with regulations governing clinical research GCP and site SOPs.
• Drafts and revises ICFs, site-specific regulatory forms, and other regulatory documents.
• Coordinates responses to IRB queries and sponsor requests for information.
• Serves as the primary regulatory point of contact for assigned studies.
• Participates in internal audits and regulatory reviews.
• Supports and mentors Regulatory Assistants in task completion and training.
• Monitors document version control and conduct routine regulatory QC checks.
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required.
• Performs other miscellaneous job-related duties as assigned by their manager.

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

• Associate or bachelor’s degree required, preferably in life sciences or health-related field.
• 3–5 years of clinical research regulatory affairs experience.
• Strong working knowledge of eRegulatory and CTMS platforms and Microsoft Office Suite.
• Familiarity with 21 CFR, GCP, HIPAA, and IRB regulations.
• Strong written and verbal communication skills.
• Certifications such as ACRP-CP, SOCRA CCRP, or RAC preferred.

Continuing Education:

• GCP (Good Clinical Practice) – Must renew every 3 years
• OSHA trainings

Physical Requirements and Environmental Factors:

• Continually required to sit.
• Continually required to utilize hand and finger dexterity.
• Continually required to talk or hear.
• The employee must occasionally lift and/or move up to 10 pounds.
• Travel is required up to 15% of the time.

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