The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
ONLY CANDIDATES WITH COSMETIC/OTC BEAUTY MANUFACTURING EXPERIENCE WILL BE CONSIDERED. PLEASE DO NO APPLY IF YOU COME FROM MEDICAL OR PHARMA
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.
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.
Capable of lifting up to 25 lbs.
Capable of standing, walking, and sitting for extended periods
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
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.
Internal Number: RAP1
About KDC/One Thibiant International
Thibiant was founded on innovation. After opening her namesake spa in Beverly Hills in 1973, French émigré Aida Thibiant and her husband, Michel, began developing their spa products under the brand Thibiant Beverly Hills. Mrs. Thibiant was referred to as the “skincare guru,” with Vogue even publishing an article about her titled “The face saver to the stars.”