Regulatory Affairs Specialist

Job Title: Regulatory Specialist Key Responsibilities

• Prepare, compile, update, and organize regulatory documentation including ingredient lists, quantitative ingredient lists, product dossiers, product information files, specifications, certificates of analysis, and safety data sheets as applicable.
• Maintain complete, traceable ingredient composition, raw-material technical data, and product records in approved R&D, regulatory, and ERP systems, including Ithos where used.
• Request, track, and review supplier documentation for completeness; follow up on missing or expired information and escalate gaps.
• Support customer regulatory questionnaires, technical information requests, and documentation packages within agreed timelines.
• Formula, Claims & Labeling Support
• Conduct initial reviews of approved cosmetic and OTC formulas against established regulatory checklists, ingredient restrictions, and customer requirements; flag questions for Regulatory Manager review.
• Assist with substantiation reviews for marketing claims, such as paraben-free, gluten-free, and animal-testing statements, and prepare draft customer attestations for authorized approval.
• Review draft ingredient declarations, label content, and product documentation for applicable market requirements; identify discrepancies and coordinate corrections with R&D, Marketing, Sales, and Quality.
• Support U.S. FDA cosmetic and OTC regulatory requirements and relevant international cosmetic requirements under the guidance of the Regulatory Manager.
• Coordinate samples, submissions, quotations, timelines, and status updates for third-party testing of cosmetic and OTC products following formula approval.
• Track stability, preservative efficacy/micro challenge, repeat insult patch testing (RIPT), and other assigned testing programs; ensure results and reports are collected and filed.
• Work with R&D chemists and Quality to summarize test results and identify incomplete, atypical, or overdue reports for review.
• Assist in compiling drug stability summaries, customer testing packages, and product dossiers; refer technical conclusions and approval decisions to appropriate subject-matter experts.
• Respond to routine customer and Sales inquiries regarding regulatory documents and testing status; escalate complex or sensitive questions.
• Partner with R&D, Quality, Operations, suppliers, and external laboratories to resolve documentation and scheduling issues.
• Support customer, quality, and regulatory audits by retrieving records, preparing evidence, and addressing assigned follow-up items.
• Maintain accurate trackers, prioritize deadlines, follow controlled procedures, and recommend improvements to document workflows and record accuracy.
• Perform other related responsibilities assigned by the Regulatory Manager.

Required Qualifications

• Approximately 3 years of experience in regulatory affairs, regulatory compliance, product development support, or a related function within cosmetics, personal care, OTC, or another regulated product environment.
• Working knowledge of FDA requirements relevant to cosmetics and/or OTC drug products, ingredient documentation, and product labeling.
• Experience compiling regulatory documents, reviewing ingredient information, coordinating product testing, or supporting customer technical requests.
• Strong written communication, attention to detail, organizational skills, and ability to manage several projects and deadlines.
• Proficiency in Microsoft Office and ability to learn regulatory databases and ERP systems.

Preferred Qualifications

• Bachelors degree in chemistry, biology, pharmaceutical sciences, or another relevant scientific discipline.
• Experience with cosmetic ingredient nomenclature (INCI), global cosmetic documentation, and product information files.
• Exposure to OTC testing, stability studies, micro challenge testing, RIPT, or third-party laboratory coordination.

Job Type & LocationThis is a Contract to Hire position based out of Edison, NJ. Pay and BenefitsThe pay range for this position is $28.00 - $32.00/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) Job Type & LocationThis is a Contract to Hire position based out of Edison, NJ. Application DeadlineThis position is anticipated to close on Nov 26, 2026. Workplace TypeThis is a fully onsite position in Edison,NJ.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.