Regulatory Affairs Associate I

Job Title: Regulatory Affairs Associate IJob Description

The Regulatory Affairs Associate I is responsible for managing activities related to marketed product variations, focusing on authoring and compiling chemistry manufacturing and control (CMC) sections to ensure timely preparation of submission documents. This role involves coordinating with all functional departments to support regulatory filings.

Responsibilities

• Manage and compile CMC sections of marketed product variations.

• Partner with RA CMC Project Leads to develop module 3 content and project timelines.

• Collaborate with diverse functional groups to ensure the file-ability and acceptance of CMC sections.

• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.

• Conduct review meetings for submission documents.

• Understand CMC expectations, including CTD content, structural, and formatting requirements.

• Maintain awareness of and utilize current best practices for regulatory business systems.

• File necessary applications and handle all government interactions for regulatory approval of products.

• Author and submit PMA supplements, 30-day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.

• Review and approve engineering study protocols/reports and validation study protocols/reports.

• Review and approve manufacturing changes for Class III implantable medical devices.

Essential Skills

• Regulatory affairs expertise

• Experience with regulatory submissions and compliance

• Familiarity with regulatory documents and quality assurance

• Understanding of US and international regulatory requirements for dossiers

• BA/BS Degree in Chemical and/or Biological Sciences or a relevant discipline

• 1-2 years of pharmaceutical experience

• 1-2 years of cross-functional project management experience

Additional Skills & Qualifications

• 1-2 years of experience in regulatory affairs, R&D, or manufacturing, specifically with CTD Module 3

• Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements

• Knowledge of FDA PMA guidance documents and CFR regulations

• Superior oral and written communication skills

• Ability to work cooperatively with global personnel

• Experience with electronic document management systems

• Ability to work independently and manage multiple projects simultaneously

• Detail-oriented, collaborative, and willing to learn

Work Environment

The role is primarily onsite at Lake County with a hybrid work schedule from Tuesday to Thursday onsite.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $30.00 - $37.00/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 Jan 12, 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 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.