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.