Cosmetics Regulatory Operations Specialist

Cosmetics Regulatory Operations Specialist

 About Cellese | AnteAGE

Cellese, Inc. | AnteAGE is a distinguished regenerative cosmeceutical brand with a robust presence in North America, currently experiencing a 25% year-over-year growth rate. We are committed to providing a positive work environment, fostering career growth, and supporting our employees in their professional development.

With more than a decade of industry experience and recent private equity backing, Cellese is poised for significant innovation, driven by a strong pipeline and multiple ongoing clinical trials. Our exclusive range of in-office and home care formulations serves medical aesthetic practices, supported by over forty direct representatives and thousands of active accounts. 

Job Title: Cosmetics Regulatory Operations Specialist

Location: Irvine, CA; On-Site Position. Applicants must be able to comfortably commute to the city of Irvine, CA.

Reports To: Project and Regulatory Manager

Job Type: Full-time

Salary Range:

·      Min: $80,000.00

·      Max: $95,000.00

*Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.*

Position Overview – Cosmetics Regulatory Operations Specialist

The Cosmetics Regulatory Operations Specialist supports Cellese’s global regulatory operations through meticulous preparation of regulatory documents, maintenance of compliance records, and coordination with international distributors. This role focuses on executing routine regulatory workflows, preparing documentation packets, tracking submissions, handling follow-ups, and ensuring that all markets consistently receive the correct and required files timely. This roles primary responsibility will be to keep global compliance running smoothly and offload routine regulatory work from the manager.

Essential Duties and Responsibilities:

Regulatory Submissions & Documentation Preparation

• Prepare standardized regulatory document packets for all global markets, including:
• FSC applications
• FDA Cosmetic Product Listings and Facility Registrations (MoCRA)
• FDA Export Certificates
• Country-specific registration forms, questionnaires, attestations
• LOA, POA, declarations, distributor letters, and compliance statements
• Create submission-ready dossiers using existing templates and previously approved content.
• Route final drafts to the Regulatory Manager for signature and approval.

Distributor Regulatory Support

• Serve as first point-of-contact for routine distributor regulatory requests.
• Maintain a distributor requirements matrix: which documents each market needs, formats, renewal cycles, and artwork restrictions.
• Respond to distributors with correct files, templates, and clarifications (after internal approval).
• Track follow-up questions and escalate complex or high-risk items only.
• Prepare complete submission packages for new distributors onboarding into new territories based on developed dossiers.

SDS, INCI, and Product Documentation Maintenance

• Prepare SDS/MSDS via approved vendors and maintain up-to-date versions.
• Maintain accurate INCI lists, technical datasheets, ingredient statements, allergen tables.
• Prepare reformatted versions of documentation (PDF, stamped, letterhead) per distributor request.
• Maintain controlled master files in SharePoint.

Artwork & Labeling Administrative Review

• Perform administrative label checks
• INCI order matches approved list
• RP addresses correct
• Label text matches approved SDS and INCI
• Volume declarations correct
• Market-specific formatting rules followed
• Track labeling changes requested by markets and escalate for approval.
• Maintain a library of current artwork for every SKU.

Sample Preparation & Testing Coordination

• Prepare test sample lists and coordinate packing/shipping for:
• PET/challenge tests
• HRIPT
• Stability
• Compatibility
• PAO
• Other clinical studies
• Complete laboratory submission forms and ensure accuracy. Maintain PO’s and Invoices.
• Maintain test logs and track completion dates.
• Organize reports into the correct regulatory folder structure.

Administrative Compliance Maintenance

• Maintain regulatory calendars (renewals, submission deadlines, certificate expirations).
• Maintain SharePoint organization with correct metadata (version, market, status).
• Update the global regulatory tracker.
• Track all outgoing documents to distributors with timestamps and files sent.
• Ensure consistency across INCI sheets, SDS, artwork, and submissions.
• Filling out distributor checklists and compliance questionnaires
• Preparing ingredient breakdowns or percentage statements
• Responding to requests for documents
• Preparing regulatory explanations based on templates you provide
• Formatting and cleaning regulatory documents before signature
• Tracking and following up on Health Authority or distributor requests
• Matching artwork and ingredients to previous submissions
• Preparing updated packets after any label or SDS change

Qualifications:

To perform this job successfully, an individual must possess the ability to perform the essential functions of the position, with or without reasonable accommodation. Reasonable accommodations will be provided to qualified individuals with disabilities in accordance with applicable laws. The requirements listed below are representative of the knowledge, skills, and/or ability required.

Education and/or Experience:

• Bachelor’s degree (science or regulatory disciplines preferred)
• 2 years working with cosmetic regulatory documentation
• Familiar with MoCRA, EU, Canada, GCC, ASEAN, LATAM frameworks
• Exceptional organization, file management, and attention to detail
• Able to follow structured processes and adhere to templates
• Strong written communication skills

Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports, memorandums, policies, directives and professional correspondences. Ability to speak effectively before groups of customers or employees of the organization.

Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee is frequently required to sit; use hands to handle or feel; and perform repetitive finger and hand movements.
• The employee is frequently required to bend, walk, talk or hear.
• The employee is frequently required to stand on feet for prolonged periods of time.
• The employee is occasionally required to reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.
• The employee is frequently required to sit for prolonged periods of time and utilize hand and finger dexterity.
• The employee must occasionally lift and/or move at least 25 pounds or more.
• The employee may be requested to travel to our other local office locations.

What We Offer:

Comprehensive Benefits: Full-time employees receive Medical, Dental, Vision, and Life Insurance coverage, with the option to enroll in supplemental plans.

Retirement Savings: Take advantage of our 401(k) Plan with employer matching.

Work-Life Balance: Enjoy paid time off, plus additional 12 paid holidays to support a healthy work-life balance.

Product Perks: Get discounts on company products and free samples to stay up to date with our latest products!