Job 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. Candidate will assist 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.
Qualifications:
• BA/BC of Science; preferably in Chemical, Biochemistry or Microbiology
• 1 years’ experience in Regulatory Affairs; cosmetic manufacturing or FDA regulated
industry highly preferable.
• Contract Manufacturing Experience Preferred