Regulatory Affairs Associate I

Job Title: Regulatory Affairs Associate I Job Description The Regulatory Affairs Associate I plays a key role in driving process excellence and issue management within Regulatory Affairs to ensure compliant, efficient, and inspection-ready operations. This position manages the Regulatory Affairs Issue and CAPA Management system, supports exception reporting and corrective actions, and partners cross-functionally to improve business processes. The role also contributes to inspection readiness, audit and inspection support, and change management activities related to legacy company integrations into Regulatory Affairs processes. Responsibilities Manage the Regulatory Affairs Issue and CAPA Management (RAIM) system to ensure issues are accurately logged, assessed, tracked, and resolved in a timely and compliant manner. Triage RAIM issue records to determine severity, impact, and appropriate next steps based on risk and regulatory requirements. Escalate issue records to Exception Reports when warranted by risk, compliance impact, or process significance. Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, define corrective and preventive actions, and drive continuous improvement in business processes. Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functional partners to ensure issue management activities are well-coordinated, effective, and aligned with organizational objectives. Provide support during internal and external audits and inspections, including coordinating documentation, tracking issues, and supporting timely and accurate responses as needed. Manage multiple legacy company integrations into Regulatory Affairs business processes through structured change plans in OneTrack. Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance and compliance expectations. Partner with stakeholders to support effective communication, implementation, and adoption of process changes across the organization. Balance and manage multiple priorities simultaneously while maintaining high standards of quality, compliance, and stakeholder engagement. Essential Skills Bachelor's degree in life sciences such as pharmacy, biology, chemistry, pharmacology, or a related discipline. Minimum of 5+ years of experience in regulatory, pharmaceutical, or medical device environments. Experience in Regulatory Affairs, Quality, process excellence, business process management, or closely related roles. Hands-on experience managing issue and CAPA systems, exception reporting, or comparable compliance and investigation workflows. Experience supporting audit and inspection readiness in a regulated environment. Strong organizational skills with the ability to manage detailed documentation and multiple concurrent activities. Strong analytical skills to assess issues, determine impact, and support data-driven decision-making. Excellent written and verbal communication skills to interact effectively with cross-functional stakeholders. Facilitation skills to lead discussions, drive alignment, and support resolution of issues. Stakeholder management skills to build relationships and collaborate effectively across functions and levels. Ability to manage multiple priorities and work effectively in a fast-paced, matrixed environment. Ability to influence outcomes without direct authority and drive process improvements through collaboration. Additional Skills & Qualifications Relevant advanced degree in science or business is preferred. Professional certifications related to Regulatory Affairs, Quality, or process excellence are a plus. Experience with business process management methodologies and tools. Experience working with structured change management tools such as OneTrack or similar systems. Demonstrated ability to support continuous improvement initiatives and process optimization. Comfort working in hybrid and cross-functional teams with diverse stakeholders. Work Environment This position is based in a hybrid work arrangement in North Chicago, with on-site presence required on Tuesday, Wednesday, and Thursday and remote work typically available on other days. The role operates within a regulated pharmaceutical and device environment that emphasizes compliance, documentation accuracy, and inspection readiness. Work involves frequent collaboration with Regulatory Affairs, Quality, and other business functions, often in a matrixed organizational structure. The assignment is planned to run through June 2027, offering a long-term opportunity to contribute to major integration and process excellence initiatives. Professional business attire is expected when on site, and work is primarily office-based with extensive use of standard business and compliance systems, including issue and CAPA management tools and change management platforms. Job Type & Location This is a Contract position based out of North Chicago, IL. Pay and Benefits The pay range for this position is $66.00 - $72.00/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 hybrid position in North Chicago,IL. Application Deadline This position is anticipated to close on Sep 2, 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.