Regulatory Specialist II

Job Title: Research Regulatory Specialist II The Research Regulatory Specialist II provides advanced regulatory support to clinical research teams by performing all duties of a Research Regulatory Specialist I and taking on additional responsibilities related to investigational new drug (IND), investigational device exemption (IDE), and biologics applications to the Food and Drug Administration (FDA). This role coordinates regulatory activities for multi-site research protocols, serves as a central liaison among regulatory bodies and research stakeholders, and ensures that all regulatory documentation meets applicable federal, institutional, and accreditation standards. Responsibilities

- Assist with the submission of research protocols and all required components to the FDA for institution-held IND, IDE, and biologics applications.
- Provide data and document collection and compilation to support regulatory filings with the FDA and other regulatory authorities.
- Assist with technical review, preparation, and submission of FDA-required reports for ongoing institution-sponsored and institution-held IND and IDE applications.
- Coordinate regulatory processes and submissions for institution-led multi-site research studies, ensuring consistency and compliance across participating sites.
- Support the Research Regulatory Manager in the orientation and onboarding of new Research Regulatory Specialists.
- Prepare and submit new research protocols, protocol amendments, continuing reviews, study modifications, and investigational product updates such as investigational brochures and device manuals, ensuring completeness, accuracy, and adherence to submission deadlines.
- Prepare and submit new informed consent documents and revisions, including required financial disclosure language, and communicate IRB requirements for re-consenting enrolled subjects.
- Ensure that all requested languages of informed consent documents are reviewed and approved by the appropriate regulatory bodies.
- Maintain compliance of all regulatory documents, including Essential Documents defined by ICH/GCP guidelines, with all applicable federal regulations, ICH/GCP guidelines, AAHRPP standards, and institutional policies and procedures.
- Monitor review, approval, and clearance activities for each research protocol, maintaining detailed, accurate, and current records throughout all stages of the regulatory process.
- Maintain regulatory documents by creating and organizing electronic folders in the eRegulatory application, filing documents electronically using standard file naming conventions, and keeping all documents current in accordance with institutional SOPs and federal, state, and IRB requirements.
- Support start-up, maintenance, and close-out activities for clinical research studies from a regulatory perspective.
- Collaborate with clinical research departments, investigators, sponsors, contract research organizations, the Office of Sponsored Programs, conflicts of interest offices, and leadership to ensure alignment and timely regulatory compliance.
- Contribute to quality assurance efforts related to regulatory documents and processes in clinical research, including oncology and other therapeutic areas.

Essential Skills

- Demonstrated experience in clinical research regulatory support, including submission and maintenance of regulatory documents and Essential Documents.
- Strong understanding of FDA regulatory requirements related to IND, IDE, and biologics applications.
- Knowledge of ICH/GCP guidelines, AAHRPP standards, and applicable federal, state, and institutional regulations governing human subjects research.
- Experience with institutional review board (IRB) processes, including protocol submissions, amendments, continuing reviews, and informed consent documents.
- Ability to collect, compile, and organize data and documents for regulatory filings with the FDA and other regulatory authorities.
- Proficiency in managing regulatory start-up, maintenance, and close-out activities for clinical research studies.
- Attention to detail and accuracy in preparing and maintaining regulatory documents and electronic regulatory files.
- Strong organizational skills to monitor and track review, approval, and clearance activities for multiple protocols.
- Effective communication skills to liaise with investigators, study teams, sponsors, contract research organizations, and administrative offices.
- Ability to work with eRegulatory systems and follow standard operating procedures for electronic document management.
- Commitment to regulatory compliance and quality assurance in clinical research, including oncology-focused studies.

Additional Skills & Qualifications

- Bachelors degree in a healthcare-related field or biological sciences and at least 2 years of work experience in a clinical research setting; OR
- Associate degree and at least 3 years of work experience in a healthcare or scientific setting, with at least 2 years in a clinical research setting; OR
- At least five years of experience working in a healthcare or scientific setting, with at least 2 years in a clinical research setting, which may include experience in an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company.
- Documented experience in submitting and maintaining regulatory documents, including research essential regulatory documents.
- Experience managing conflicts of interest and financial conflicts of interest documentation.
- Experience with ClinicalTrials.gov registration and maintenance.
- Background in oncology clinical research is highly beneficial.
- Familiarity with quality assurance processes in clinical research and regulatory compliance.
- Ability to support training and orientation of new regulatory team members.

Work Environment This position operates in a remote work environment, providing regulatory support to clinical research teams through electronic systems and virtual collaboration tools. The role relies heavily on eRegulatory applications and standardized electronic document management processes, requiring consistent adherence to institutional standard operating procedures and regulatory requirements while working independently and coordinating with geographically dispersed study teams and stakeholders.
Job Type & Location
This is a Permanent position based out of Altamonte Springs, FL.
Pay and Benefits
The pay range for this position is $76960.00 - $79040.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Oct 9, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability,
please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.