Regulatory Affairs Specialist - Cosmetic

ONLY CANDIDATES WITH COSMETIC/OTC BEAUTY MANUFACTURING EXPERIENCE WILL BE CONSIDERED. PLEASE DO NO APPLY IF YOU COME FROM MEDICAL OR PHARMA

General Description:

The Regulatory Affairs Associate is responsible with formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations. Assists with technical/regulatory aspects of product development.  Under general supervision, liaison between R&D, Marketing/Customer, and Quality team members to provide support required for successful launch of new & existing products.

Specific Responsibilities & Duties:

• Promotes a safe working environment and adheres to Health, Safety and Environmental procedures, company safety rules, Current Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) at all times.
• Manages and prepares documentation for all government registrations annually, i.e. FDA, State or EPA product registration.
• Maintain all registrations and certificates for OTC, Personal Care, i.e. ISO, Organic Certification, and Kosher Certification.
• Prepare annual report to City, State, and Federal, i.e. Annual Drug Product Review, hazardous waste management to City, storm water report to State.
• Prepare documents required for export registration, i.e. manufacturing certificate, microbial certificate.
• Facilitate certification audit for facility, i.e. ISO, Kosher, Organic, etc. Prepare product safety assessment documents i.e. finished good MSDS for new products
• Review regulation changes annually and take any required action
• Review ingredient list against actual formula to ensure label deck accurately reflects the product content. (using Excel).
• E-file all OTC products. Revised existing or new as needed.
• Assist to ensure quality records meet FDA and ISO requirements.
• Handle ISO, Kosher and Organic certification renewal -- arrange for annual audit, work with production to ensure records are updated and ready for audit.
• Assists with review, assessment, and remediation of regulatory records.
• Creates and maintains technical documentation files for both domestic and international regions.
• Obtain technical/regulatory documentation from raw material vendors.
• Compiles documentation for global product registrations.
• Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.
• Reviews labeling to ensure compliance with domestic and international standards and regulations and consistency with regulatory submissions/approvals.
• Reviews advertising and promotional materials to ensure compliance with product claims.
• Assists with the support of product launches for new catalog numbers and/or trade names for on-market product lines.
• Assists with the approval of distribution of product to domestic and international regions.
• Interfaces with Marketing and Commercial teams to support customer and private label initiatives.
• Assists with maintenance of processes and procedures related to Regulatory Affairs activities; develops SOP internal procedures and tools.
• Assists with investigations and executes corrective actions for Quality Incidents (QIs) and Corrective and Preventive Actions (CAPAs) affecting Regulatory Affairs.
• Organizes and maintains hard copy and electronic department files.
• Adds and maintains information contained in Registration Lists and the Global Regulatory Information Database.
• Responds to general product and regulatory inquiries from internal stakeholders
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Other duties and responsibilities as may be required by management team.