Regulatory Affairs Specialist

1 day ago


Agoura Hills, California, United States Brazilian Professionals Full time
Job Overview

Brazilian Professionals is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with international regulations and guidelines for our cosmetic products.

Key Responsibilities:

  • Manage and prepare documentation for international product registrations
  • Stay up-to-date on international cosmetic regulations, including formulations, labeling, and packaging changes
  • Maintain all registrations and certificates for international registrations, including CPNP certifications
  • Provide correspondence to international distributors on localization matters regarding registration and compliance
  • Prepare all related documents required for export registration, including product composition, ingredient SDS, COAs, packaging declarations, and manufacturing certificates
  • Prepare all company finished good SDS documents
  • Review regulation changes annually and take required action
  • Review ingredient lists against actual formulas to ensure label decks accurately reflect product content
  • Create and maintain technical documentation files for domestic and international regions
  • Obtain technical/regulatory documentation from raw material vendors
  • Compile documentation for global product registrations
  • Assess product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations
  • Review labeling to ensure compliance with domestic and international standards and regulations and consistency with regulatory submissions/approvals
  • Assist with maintenance of processes and procedures related to Regulatory Affairs activities; develop SOP internal procedures and tools
  • Assist with investigations and execute corrective actions for Quality Incidents (QIs) and Corrective and Preventive Actions (CAPAs) affecting Regulatory Affairs
  • Organize and maintain hard copy and electronic department files
  • Respond to general product and regulatory inquiries from internal stakeholders

Requirements:

  • High school education or equivalent
  • BA/BC of Science; preferably in Chemical, Biochemistry, or Microbiology
  • 1-3 years experience in Regulatory Affairs in the cosmetic product space
  • Contract Manufacturing Experience Preferred
  • Knowledgeable with international regulations and able to prepare documentation and communicate with international regulatory consultants
  • 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 of cosmetic products
  • Demonstration of continual education (through membership in recognized organizations, seminars attended, and 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
  • Good interpersonal and customer service skills
  • Constantly work to improve processes
  • Self-motivated and able to work independently
  • Must have cosmetic/OTC product regulatory experience

Work Environment:

Office environment. Noise level is low to moderate. Proper lighting and ventilation.



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