Regulatory Specialist

Job Title: Regulatory Specialist

Job Description

The Regulatory Specialist supports key regulatory submissions by coordinating, tracking, and organizing documentation for IND filings. This role focuses on regulatory operations and document management, ensuring that all records are accurate, compliant, and audit-ready while partnering closely with internal stakeholders in a pharmaceutical, biotech, or drug discovery environment.

Responsibilities

• Support IND filing activities by coordinating and tracking regulatory documents throughout the submission lifecycle.
• Manage document flow to ensure proper version control, routing, and archival practices are consistently followed.
• Maintain regulatory submission trackers and document inventories to provide clear visibility into filing status and outstanding items.
• Coordinate collection of required documents from internal stakeholders and follow up to obtain missing information.
• Track Module 2 documentation and verify completeness of all required components prior to submission.
• Support regulatory operations processes and document management activities in alignment with internal procedures and regulatory expectations.
• Ensure regulatory records are organized, audit-ready, and compliant with established company procedures and regulatory standards.
• Assist with electronic document management systems (eDMS) and filing platforms to store, organize, and retrieve regulatory documentation.
• Monitor filing timelines and proactively follow up with stakeholders on outstanding documentation to keep submissions on schedule.
• Maintain accurate records of submissions, amendments, and regulatory correspondence to support traceability and compliance.

Essential Skills

• 2-5+ years of experience in Regulatory Affairs Operations, Regulatory Document Management, or Regulatory Publishing support.
• Hands-on experience supporting IND filings within a pharmaceutical, biotech, or drug discovery environment.
• Familiarity with Module 2 documentation and its components in the context of regulatory submissions.
• Experience with document tracking, document routing, and version control processes in a regulated environment.
• Knowledge of eCTD structure and regulatory filing requirements for IND submissions.
• Proficiency with electronic document management systems such as Veeva, MasterControl, SharePoint, or similar platforms.
• Strong organizational skills with the ability to manage multiple documents, tasks, and timelines simultaneously.
• High attention to detail to ensure accuracy, completeness, and compliance of all regulatory documentation.

Additional Skills & Qualifications

• Experience in regulatory, IND, or related regulatory operations work.
• Comfort working with electronic filing platforms and eDMS tools.
• Ability to collaborate effectively with cross-functional internal stakeholders.
• Strong written and verbal communication skills for clear documentation and stakeholder follow-up.

Work Environment

This position operates in a remote work environment, providing flexibility in work location while maintaining close collaboration with regulatory and cross-functional teams through digital communication and document management systems. The role relies heavily on electronic tools and platforms, including eDMS solutions such as Veeva, MasterControl, and SharePoint, to manage, track, and archive regulatory documentation. Working hours are typically aligned with standard business hours, with the need to meet filing timelines and regulatory deadlines. The remote setting requires a reliable workspace, consistent internet access, and the ability to manage tasks independently while adhering to company procedures and regulatory standards.

Job Type & Location

This is a Contract position based out of Miami, FL.

Pay and Benefits

The pay range for this position is $38.00 - $50.00/hr.

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.

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 Sep 25, 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 actalentaccommodation@actalentservices.com 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.