• Certified Regulatory Specialist III

    Actalent (Orlando, FL)


    Job Title: Research Regulatory Specialist III

     

    *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 sciences with at least 4 years of clinical research experience, or an Associate Degree with 5 years clinical research experience

    + Experience in submitting and maintaining regulatory documents, including conflicts of interest documentation.

    + MUST HAVE ACTIVE CERTIFICATION through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&R. Candidates without an active certification will not be considered.

    + Must have oncology clinical research experience or other complex therapeutic area

    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 9, 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 [email protected] (%[email protected]) for other accommodation options.