Remote Research Regulatory Specialist II

Actalent; Florida; Remote; USD 77,000 - 79,000; Full time

Benefits offered by this job

Medical, Dental, Vision

PTO from Day One

403-B Retirement Plan

Job summary

Actalent is seeking a Research Regulatory Specialist II to provide advanced regulatory support for clinical research teams, focusing on IND, IDE, and biologics applications with the FDA. The role coordinates regulatory activities for multi-site protocols and ensures compliance with federal, institutional, and accreditation standards.

The candidate will assist with submissions, document collection, and regulatory filings, while supporting onboarding of new specialists and maintaining regulatory

Qualifications

• Experience providing regulatory support for clinical research and regulatory filings.
• Strong knowledge of FDA IND/IDE and biological products regulations.
• Familiarity with ICH/GCP guidelines and AAHRPP standards.
• Experience with IRB submissions, amendments and continuing reviews.
• Ability to gather, organize data for FDA filings and other authorities.

Responsibilities

• Assist with FDA protocol submissions for IND/IDE and biologics applications.
• Compile data and documents to support regulatory filings with FDA and others.
• Review and submit FDA-required reports for ongoing IND/IDE applications.
• Coordinate regulatory processes for multi-site studies across sites.
• Support onboarding of new Regulatory Specialists with guidance and training.
• Prepare new protocols, amendments, continuing reviews, and document updates.

Skills

IRB processes

FDA IND/IDE

ICH/GCP

Regulatory filings

Documentation management

Attention to detail

Regulatory coordination

Communication skills

Education

Bachelor's degree in healthcare or biological sciences

Associate degree + 3 years in healthcare/science

5+ years in healthcare/scientific with clinical research

Tools

eRegulatory systems

Job description

Actalent is seeking a Research Regulatory Specialist II to provide advanced regulatory support for clinical research teams, focusing on IND, IDE, and biologics applications with the FDA. The role coordinates regulatory activities for multi-site protocols and ensures compliance with federal, institutional, and accreditation standards.

The candidate will assist with submissions, document collection, and regulatory filings, while supporting onboarding of new specialists and maintaining regulatory