Regulatory Assistant

Job Description

Job Description

Summary:  The Regulatory Assistant supports the company’s regulatory compliance activities for skincare, cosmetic, personal care, and related consumer products sold in the United States and international markets. This position maintains regulatory documentation, assists with product and packaging reviews, tracks regulatory requirements and deadlines, and coordinates information among internal departments, headquarters, manufacturers, suppliers, laboratories, consultants, and business partners.

The Regulatory Assistant must be highly organized, detail-oriented, and able to manage multiple products, documents, and deadlines. The position identifies and escalates potential compliance concerns but does not independently approve formulas, labels, claims, product registrations, or regulatory strategy unless specifically authorized.

Essential Duties and Responsibilities  include the following. Other duties may be assigned.

Regulatory Documentation and Records

• Maintain accurate and organized regulatory files for products, ingredients, formulas, packaging, testing, claims, safety information, and supporting documentation.
• Collect, review, organize, and track product specifications, ingredient lists, certificates of analysis, safety data sheets, test reports, manufacturing information, and supplier documentation.
• Maintain regulatory databases, product trackers, registration records, standard operating procedures, and departmental reference materials.
• Monitor document requests, formula changes, artwork revisions, registration status, renewals, corrective actions, and regulatory deadlines.

Product, Labeling, and Claims Support

• Assist with reviews of product labels, cartons, inserts, website content, marketing materials, and product claims for consistency with applicable requirements and approved product information.
• Identify missing, inconsistent, or potentially noncompliant information and promptly escalate concerns to management.
• Support regulatory assessments for new products, reformulations, packaging changes, product launches, and product discontinuations.
• Coordinate regulatory feedback with Marketing, Sales, Product Development, Quality, Operations, Customer Care, E-Commerce, and other departments.

Registrations and Regulatory Compliance

• Assist with U.S. cosmetic facility registration, product listing, recordkeeping, adverse-event documentation, and other activities required under applicable FDA requirements and company procedures.
• Support product registrations, notifications, renewals, retailer compliance requests, and market-entry documentation in the United States and international markets.
• Assist with documentation required for products distributed in Canada, the United Kingdom, the European Union, and other markets.
• Monitor regulatory developments affecting cosmetics, skincare, personal care products, ingredients, labeling, packaging, claims, product safety, and environmental requirements.

Cross-Functional and External Coordination

• Communicate with headquarters, manufacturers, laboratories, consultants, distributors, suppliers, and business partners to obtain required regulatory information.
• Assist with responses to regulatory questions from customers, retailers, business partners, and internal departments.
• Support investigations and documentation involving product complaints, adverse events, labeling issues, or other potential compliance concerns.
• Prepare reports, summaries, presentations, and supporting materials for management and maintain the confidentiality of product, formula, supplier, and business information.

Qualifications & Experience

• Associate degree or bachelor’s degree in regulatory affairs, chemistry, biology, cosmetic science, pharmaceutical science, business administration, or a related field preferred.
• One to three years of experience in regulatory affairs, quality assurance, product development, document control, legal administration, or a related support function preferred.
• Experience in cosmetics, skincare, personal care, consumer products, pharmaceuticals, food, or another regulated industry preferred.
• Entry-level candidates with relevant education and strong organizational and analytical skills may be considered.
• Familiarity with U.S. cosmetic regulations, the Modernization of Cosmetics Regulation Act, FDA labeling expectations, or international cosmetic requirements preferred.
• Proficiency with Microsoft Excel, Word, PowerPoint, Outlook, shared document systems, and project-tracking tools.
• Japanese-language ability or experience working with a Japanese parent company is helpful but not required.

Key Competencies

• Accuracy and attention to detail
• Regulatory awareness and continuous learning
• Organization, planning, and deadline management
• Written and verbal communication
• Problem identification and sound escalation judgment
• Cross-functional and international collaboration
• Accountability, confidentiality, and professionalism

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

Customer Service

Works well with customers and business partners, both internal and external; promotes a positive image of the company; responds to requests for service and assistance; meets commitments; and strives to resolve issues accurately and promptly.

Teamwork

Values the input and knowledge of other employees; asks for and offers assistance when needed; builds trust and respect among coworkers; and works effectively across departments and with international colleagues toward common goals.

Adaptability or Flexibility

Remains open to change and new information; adapts work methods in response to changing regulations, priorities, and unexpected obstacles; and is able to manage frequent changes, delays, or urgent requests.

Ethics

Upholds DHC’s Code of Conduct; treats coworkers, customers, and business partners with respect; behaves fairly and ethically; maintains confidentiality; and communicates compliance concerns honestly and appropriately.

Professionalism

Approaches others positively; reacts well under pressure; treats others with respect and consideration; accepts responsibility for actions; follows through on commitments; and represents the company professionally.

Communication

Communicates clearly and accurately in positive or difficult situations; listens and seeks clarification; writes clearly and informatively; reviews work for accuracy, spelling, and grammar; and adjusts communication to the audience.

Continual Learning

Grasps the essence of new regulatory information; applies newly gained knowledge and skills on the job; recognizes strengths and development needs; seeks feedback; and pursues opportunities to strengthen regulatory knowledge.

Interpersonal Skills

Listens without interrupting; maintains composure; remains open to other ideas; works constructively through differences; and focuses on solving issues rather than assigning blame.

Diversity

Demonstrates knowledge of EEO policy; shows respect and sensitivity for cultural differences; supports a harassment-free environment; and works effectively with colleagues and partners from different backgrounds.

Safety

Follows safety and security procedures; reports unsafe conditions; uses equipment and materials properly; and supports product safety and workplace compliance requirements.

Problem Solving and Decision Making

Uses appropriate approaches and available information to identify, analyze, and resolve regulatory or documentation issues; distinguishes matters that can be handled within established procedures from those requiring escalation.

Planning and Organizing

Plans and organizes work; establishes priorities based on regulatory risk, deadlines, and business needs; maintains accurate tracking systems; and remains accountable for timely completion of assigned responsibilities.

Quality and Attention to Detail

Reviews detailed information carefully; identifies inconsistencies, omissions, and potential risks; maintains accurate records; and completes work in accordance with established standards and procedures.

Change Management

Adapts to evolving regulatory requirements and competing demands; supports changes to procedures, documentation, systems, and product requirements; and helps internal partners understand and implement necessary compliance actions.