Certified Regulatory Specialist II

Talentify; Charlotte (NC); Remote; USD 60,000 - 80,000; Full time

Job summary

A forward-thinking company is seeking a Research Regulatory Specialist II to provide essential regulatory support to the research team. This role involves assisting in the submission of investigational new drug and device applications to the FDA, ensuring compliance with federal regulations, and coordinating regulatory activities for multi-site research protocols. Ideal candidates will have a background in healthcare or biological sciences, along with clinical research experience. Join this innovative firm and contribute to groundbreaking research initiatives while enjoying a fully remote work environment and a comprehensive benefits package.

Benefits

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Life Insurance

Short and Long-term Disability

Health Spending Account

Transportation Benefits

Employee Assistance Program

Paid Time Off

Qualifications

• Bachelor’s degree in healthcare or biological sciences required.
• 2+ years of clinical research experience preferred.

Responsibilities

• Assist with regulatory submissions to the FDA for IND and IDE applications.
• Coordinate regulatory processes for multi-site research projects.

Skills

Regulatory Document Submission

Clinical Research Experience

Technical Review

Data Compilation

IRB Compliance

Education

Bachelor’s Degree in Healthcare or Biological Sciences

Associate Degree with Clinical Research Experience

Job description

Job Title: Research Regulatory Specialist II

Location: REMOTE

*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

Job Description

The Research Regulatory Specialist III provides regulatory support to the research team, assisting investigators with investigational new drug (IND), investigational device exemption (IDE), and biologics applications to the FDA. The role also involves coordinating regulatory activities for multi-site research protocols and acting as a liaison between various stakeholders including the IRB, FDA, study teams, and sponsors.

Responsibilities

• Assist with the submission of research protocols and documents to the FDA for investigational new drug (IND), investigational device exemption (IDE), or biologics applications.
• Collect and compile data and documents for regulatory filings with the FDA and other authorities.
• Conduct technical reviews and prepare reports for ongoing IND/IDE applications.
• Coordinate regulatory processes and submissions for multi-site research projects.
• Support the orientation of new Research Regulatory Specialists.
• Prepare and submit new research protocols, amendments, continuing reviews, and other modifications.
• Ensure completeness and accuracy of documents while meeting submission deadlines.
• Prepare and submit new and revised informed consent documents, ensuring compliance with IRB requirements.
• Ensure all regulatory documents comply with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and organizational policies.
• Monitor review, approval, and clearance activities for each research protocol, maintaining detailed records.
• Maintain regulatory documents electronically, following standard criteria and current regulations.

Essential Skills

• Bachelor’s degree in healthcare 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.
• Experience in submitting and maintaining regulatory documents, including conflicts of interest documentation.
• Certification through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&R.

Additional Skills & Qualifications

• Experience in oncology, quality assurance, regulatory compliance, and regulatory submission.

Pay and Benefits

The pay range for this position is $38.00 - $40.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 7, 2025.

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 [e-mail] for other accommodation options.