Regulatory Affairs Specialist

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.

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