Regulatory Affairs & Documentation Specialist

The Regulatory Affairs & Documentation Specialist is responsible for 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 of the R&D Department and cross supporting Marketing and Operation Departments, to provide the support required for a successful launch of new & existing products for both domestic and international distribution.

INDUSTRY EXPERIENCE REQUIRED – HAIR CARE, SKIN CARE

Specific Responsibilities & Duties · ·

Manages and prepares documentation for all international product registrations

Stays up to date on all international cosmetic regulations (EU and other territories) including formulations, labeling and packaging related changes.

Maintain all registrations and certificates for all 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, i.e. product composition, ingredient SDS, COAs, packaging declarations, manufacturing certificates etc.

Prepare all company finished good SDS documents.

Review regulation changes annually and take any required action ·

Review ingredient list against actual formula to ensure label deck accurately reflects the product content

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.

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. · ·

Responds to general product and regulatory inquiries from internal stakeholders

Carries out duties in compliance with established business policies.

Other duties and responsibilities as may be required by the management team.

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. · 1-3 years experience in Regulatory Affairs in the cosmetic product space.

Contract Manufacturing Experience Preferred.

Knowledgeable with international regulations and be able to prepare documentation & 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, & 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.