Certified Regulatory Specialist III

Job Title: Research Regulatory Specialist III (MUST BE CERTIFIED)

Job Description

The Research Regulatory Specialist III provides advanced regulatory support to the research team. This role involves assisting research investigators with investigational new drug (IND), investigational device exemption (IDE), and biologics applications to the FDA. The position also coordinates regulatory activities for multi-site research protocols.

Responsibilities

• Assist with the submission of research protocols and required documents to the FDA for investigational new drug (IND), investigational device exemption (IDE), or biologics applications.
• Provide data and document collection and compilation for regulatory filings with the FDA and other regulatory authorities.
• Assist in the technical review and submission of FDA-required reports for ongoing sponsored and held IND/IDE applications.
• Coordinate regulatory processes and submissions for multi-site research.
• Help orient new Research Regulatory Specialists.
• Prepare and submit new research protocols, amendments, continuing reviews, and other study modifications.
• Prepare and submit informed consent documents, ensuring all languages are reviewed and approved.
• Ensure all regulatory documents comply with Federal regulations, ICH/GCP guidelines, and institutional policies.
• Monitor required review, approval, and clearance activities for each research protocol, maintaining accurate and current records.
• Maintain regulatory documents by creating electronic folders, filing them electronically, and keeping all documents current as per standard operating procedures.

Essential Skills

• Experience in clinical research, oncology, quality assurance, and regulatory compliance.
• Expertise in regulatory document submission and maintenance.
• Proficiency in regulatory processes, start-up, maintenance, and close out.

Additional Skills & Qualifications

• Bachelor’s degree in healthcare-related field or biological sciences with at least 2 years of clinical research experience, or an Associate Degree with 3 years of healthcare or scientific experience, including 2 years in clinical research.
• Certification through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&R.

Work Environment

This position is remote, allowing for flexible working arrangements.

*Applicants must reside in one of the following states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia

This is a Permanent position based out of Altamonte Springs, FL.

The pay range for this position is $78000.00 - $85000.00/yr.

Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance Paid Time Off from Day One 403-B Retirement Plan 4 Weeks 100% Paid Parental Leave Career Development Whole Person Well-being Resources Mental Health Resources and Support

This is a fully remote position.

This position is anticipated to close on Feb 27, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $78,000 - $85,000