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.
Physical Requirements
Capable of lifting up to 25 lbs.
Capable of standing, walking, and sitting for extended periods Qualifications:
High school education or equivalent.
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 Knowledgeable with international regulatory and be able to prepare documentation & communicate with International agencies QA / QC External/ Internal Audit Product Review/Release Technical Writer.
Good oral and written communication skills Document Control/Batch Records / Change Control Cosmetic ingredient knowledge, INCI Must have Microsoft Professional edition software skills Must have project management skills Knowledge of cGMP in pharmaceutical or cosmetic products.
Knowledge of FDA, EPA, and State regulation for cosmetic and OTC drugs.
Demonstration of continual education (through membership in recognized organizations, seminars attended, & certifications.
Strong time-management, organizational, planning people and leadership skills Advanced PC Knowledge i.e.
MS Office Suite (Excel, Word, Outlook) and management system is required .
Advanced English communications skills: speaking, reading, and writing.
Flexibility to work long hours during peak season or special schedules as needed to satisfying job requirements.
Ability to multi-task and follow through on project assignments Ability to quickly remedy procedural problems Good interpersonal and customer service skills Constantly work to improve processes Self-motivated and able to work independently.
Job Requirements:
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.