Title:  Senior Associate, Regulatory Affairs

Position Summary

Responsible for collecting and reviewing regulatory and technical product quality documentation from manufacturers and suppliers and preparing regulatory documentation in support of registration efforts for cosmetic and OTC monograph products.

Review ingredient lists, raw material docs, formulations, packaging, DFP and claims for new and existing products.

Manage the regulatory documentations from contract manufacturers and raw material suppliers (SDS, CoA, COO).

Monitor regulatory agency websites, blog, and social media to stay on top of regulatory changes and restricted ingredient lists to ensure the safety and efficacy of all products. Up to date with current MoCRA and CARES Act requirements

This position will cover USA, Canada, EU and other international markets to implement and contribute to creating global processes and systems.  

Responsibilities

• Prepare and coordinate documentation to support new regulatory submissions, changes to existing registrations, and product renewals, ensuring accuracy, technical soundness, and compliance with applicable regulations and guidelines.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Supply Chain, Legal, and Marketing to compile, review, and submit regulatory documentation in alignment with project timelines and priorities.

• Provide regulatory input and risk assessment for OTC drug and cosmetic product claims; substantiate claims in compliance with FDA, FTC/NAD requirements.

• Ensure all ingredients and raw materials are in compliance with regulatory authorities (FDA, Health Canada, EU, Prop 65, PCPC) and client’s restricted substance list.
• Prepare and submit CARES Act reports, NDC drug listings, MoCRA registrations, WERCS entries, and other regulatory filings.
• Maintain product data in regulatory databases such as WERCS to support customer, retailer, and internal safety requirements.
• Review and approve artwork and labeling (Drug Facts, INCI, PDP) to ensure compliance with FDA, Health Canada, EU, and internal requirements.
• Review product formulas for compliance with relevant market regulations and provide regulatory guidance for product development/planning for the product
• Evaluate raw material documentation, including safety data sheets, technical data sheets, and certificates of origin, ensuring compliance with internal and regulatory standards.
• Create and review ingredient lists for U.S., Health Canada, and international formats.
• Some knowledge in Health Canada OTC-drug and Cosmetic registrations such as DIN, NHP & CNF Registrations
• Ensure proper labeling and INCI declarations, including review of fragrance allergens, California SB-312 compliance and registrations, and adherence to applicable regulations (e.g., FDA, Health Canada, EU).
• Review and approve formulations and components in PLM (Product Lifecycle Management) systems.
• Support Art team in creating master dyeline/product label templates, drug facts panel, principal display panel and ensure all labelling requirements are met
• Review and author SOPs and work instructions as required to assure consistency and compliance
• Review stability protocols and data, technical procedures, certificates of analysis and other product data to ensure quality and appropriateness to support registration efforts.
• Support in-country regulatory activities by addressing questions and issues that arise as part of the registration and re-registration process as well as questions pertaining to product changes.

Qualifications

• Bachelor’s degree in a related field, required
• 2-4 years of experience working in Regulatory Affairs with cosmetics or OTC monograph products
• Experience working with internationally based colleagues preferred.
• Experience operating in a matrix reporting environment preferred.
• Experience reviewing technical documentation such as certificates of analysis, test reports or similar documentation required.
• Ability to define and solve problems, collect data, establish facts, and draw valid conclusions.
• Proficient in the preparation and formatting of electronic documents utilizing Microsoft Word and Adobe Acrobat.
• Effective oral and written communication skills and the ability to effectively create and foster cross-functional partnerships.
• Ability to multi-task under pressure.

The presently-anticipated base compensation pay range for this position is $99,500 to $110,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.