Regulatory Affairs Associate I

Job Title: Regulatory Affairs Associate I / Technical Project Manager - Regulatory Affairs CMC

Job Description

This role serves as a Technical Project Manager within Regulatory Affairs CMC, focused on supporting marketed product variations and post-approval regulatory changes. You will work at the intersection of Regulatory Affairs, CMC, Manufacturing, Process Development, Analytical Sciences, and other technical functions to develop submission strategies, manage timelines, coordinate cross-functional activities, and ensure the timely delivery of high-quality regulatory submissions. The position is highly collaborative and requires strong project management skills, excellent communication abilities, and a foundational understanding of regulatory submissions, electronic Common Technical Documents (eCTD), and CMC documentation.

Responsibilities

• Manage regulatory activities related to marketed product variations and post-approval changes, ensuring compliance with applicable requirements.
• Compile, author, and manage Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions for assigned products and projects.
• Ensure CTD and eCTD content meets required structural, formatting, and regulatory standards for U.S. and international dossiers.
• Partner closely with Regulatory Affairs CMC Project Leads to develop Module 3 content and overall submission strategies.
• Coordinate the preparation of submission documents and responses to regulatory agency inquiries, working with subject matter experts across functions.
• Serve as the project manager for assigned regulatory initiatives, driving timelines, deliverables, and stakeholder accountability.
• Interface with subject matter experts in R&D, Manufacturing, Process Development, Analytical Sciences, Quality, and other technical groups to gather information and resolve issues.
• Independently facilitate project team meetings and document review sessions to keep projects on track and address open items.
• Monitor project progress, identify risks, and proactively adjust plans as priorities evolve to maintain delivery commitments.
• Ensure regulatory submissions are completed thoroughly, accurately, and on schedule with minimal oversight.
• Act as a central point of coordination between Regulatory Affairs and supporting functional groups to align expectations and deliverables.
• Communicate project status, risks, timelines, and action items clearly and regularly to stakeholders.
• Build strong working relationships with global teams to support successful regulatory filings in multiple regions.
• Coordinate cross-functional activities and documentation to support CMC-related activities within pharmaceutical development, manufacturing, and regulatory environments.
• Manage multiple projects simultaneously, prioritizing tasks effectively and maintaining high standards of organization and documentation.

Essential Skills

• Bachelor"s degree in Chemistry, Biology, Life Sciences, or a related scientific discipline.
• 1-2 years of pharmaceutical industry experience.
• 1-2 years of cross-functional project management experience, preferably in a technical or scientific environment.
• Strong project management fundamentals, including timeline management, risk identification, and stakeholder coordination.
• Experience coordinating technical documentation and interacting with scientific subject matter experts.
• Working knowledge of regulatory submission components and eCTD structures.
• Experience working with electronic document management systems.
• Strong organizational skills with the ability to manage multiple projects simultaneously and work independently.
• Excellent communication skills, including the ability to influence and drive outcomes without direct authority.
• Strong attention to detail and a commitment to accuracy in documentation and submissions.
• Foundational understanding of Chemistry, Manufacturing, and Controls (CMC) documentation and processes.
• Ability to coordinate cross-functional teams and drive deliverables to meet regulatory timelines.

Additional Skills & Qualifications

• Experience in Regulatory Affairs, CMC, R&D, Manufacturing, Process Development, or Analytical Sciences.
• Familiarity with CTD and eCTD submission structures, particularly Module 3.
• Knowledge of U.S. and international regulatory requirements for product dossiers.
• Experience supporting regulatory submissions and post-approval changes for pharmaceutical products.
• Prior experience as a Regulatory Associate, Regulatory Project Coordinator, or Project Manager within the life sciences industry.
• Exposure to Regulatory Affairs and/or CMC activities within a pharmaceutical environment.
• Experience managing complex cross-functional projects and timelines.
• Ability to work effectively in a global, cross-functional setting and collaborate with diverse technical teams.
• Strong stakeholder management skills and the ability to build productive relationships across R&D, Manufacturing, Process Development, Analytical Sciences, Quality, and Regulatory groups.

Work Environment

This position is based in Lake County, IL and follows a hybrid work schedule, with on-site presence required Tuesday through Thursday and remote work typically available on other days. The role is offered as a 1-year contract, and candidates may relocate at their own expense if desired. You will work in a collaborative, cross-functional environment that brings together Regulatory Affairs, CMC, Manufacturing, Process Development, Analytical Sciences, Quality, and other technical teams. Daily work involves extensive interaction with electronic document management systems, preparation of CTD/eCTD submissions, and participation in project team and document review meetings. The environment emphasizes clear communication, high-quality documentation, adherence to regulatory standards, and effective project management within a structured yet dynamic setting.

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits

The pay range for this position is $26.00 - $30.00/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 hybrid position in North Chicago,IL.

Application Deadline

This position is anticipated to close on Jul 8, 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.