About the Company PakLab is a leading contract manufacturer specializing in health & beauty and household products. With three decades of professional product development service experience, we are setting a new standard in contract manufacturing. With our innate understanding of product design, development and formulation, as well as manufacturing and packaging mechanics, we work with our clients as a fully integrated strategic partner, creating innovative products from the bottom up. We employ a world-class team of Engineers, Chemists, Microbiologists, Lab Technicians, Designers, and Packaging Specialists who oversee the process from conception to completion. Service is the cornerstone of our corporate culture, and we will devote whatever resources are necessary to ensure a complete understanding of our customers' needs in order to achieve their goals. Job Summary The Regulatory Affairs Specialist is responsible for managing regulatory activities for cosmetic and OTC products, as applicable to the company's customer base. Responsibilities include, but are not limited to, reviewing formulas, raw materials, ingredients, and finished products for compliance with applicable FDA, MoCRA, EU, and global requirements; managing OTC drug product registrations and listings; preparing and maintaining technical dossiers, Product Information Files (PIFs), safety assessments, and supporting regulatory documentation; reviewing product artwork, labeling, packaging, and marketing claims for regulatory compliance; maintaining required company certifications, licenses, facility registrations, permits, and other regulatory authorizations; monitoring renewal requirements and ensuring regulatory commitments remain current; and serving as a regulatory liaison to customers, R&D, Quality Assurance, Operations, Commercial, and other cross-functional teams. Essential Duties and Responsibilities Prepare, review, and submit product registrations, permits, and licensing as applicable to customer and regulatory requirements. Ensure packaging, labeling, and product claims comply with FDA, FTC, EU, and other applicable regulatory entities as applicable. Oversee and maintain updated licenses, certifications, permits, and registrations. Support Regulatory, customer, and certification audits. Support international product registrations and compliance with country-specific requirements as applicable. Monitor and interpret changes in applicable regulations, and certifications (HALAL, Organic, NSF, Gluten Free, RSPO), and communicate impacts to internal stakeholders. Support with correspondences to applicable regulatory authority inquiries, certification bodies, and registrars. Collaborate with R&D and Marketing to oversee, manage, and review formulas, product claims, label, and artwork for compliance. Prepare and maintain Safety Data Sheets (SDS), technical files, and product information files (PIFs). Participate in cross-functional project teams to ensure applicable regulatory considerations are addressed during product development. Perform other duties as assigned by the direct manager. Required Skills and Abilities Strong knowledge of FDA, FTC, EU, and other global regulatory requirements for cosmetics, OTC drugs, dietary supplements, or consumer products. Strong familiarity with MoCRA (Modernization of Cosmetics Regulation Act) in the US, EU cosmetics regulations, and global compliance frameworks. Excellent attention to detail and documentation accuracy. Strong organizational, project management, and recordkeeping skills. Ability to analyze regulatory requirements and apply them to product development and labeling. Effective written and verbal communication skills. Proficiency in Microsoft Office and familiarity with regulatory submission systems. Ability to work independently and collaborate across departments. Education and Experience Requirements Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, or related field required. 3-5 years of experience in regulatory affairs, compliance, or quality assurance in manufacturing or consumer product industries. Experience with US & international regulatory submissions and product registrations preferred. Background in cosmetics, pharmaceuticals, dietary supplements, or consumer packaged goods strongly preferred. Physical Demands Prolonged periods of sitting at a desk and working on a computer. Ability to lift up to 15 pounds occasionally. Working Conditions Work performed primarily in an office environment with occasional visits to laboratory or production areas. Flexibility to work extended hours or weekends to meet submission deadlines or regulatory requirements.

Pay Range:

$75,000-105,000 yearly Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice. Equal Employment Opportunity (EEO) Statement Universal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

Pay:

$75,000.00 - $105,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Health savings account Paid time off Vision insurance

Work Location:

In person