Regulatory and Quality Manager

At K18, we're about hair freedom for all-engineered with biotech. We are on a mission to liberate expression. To make the impossible possible with the right technology. To build a community of forward thinkers, risk takers, and rabble rousers. To bring fearless innovation forward and push boundaries past where we thought they could go.

Position Overview

The Regulatory and Quality Manager will be a key member of the NPD/Compliance team and will be responsible for ensuring all proposed ingredients, formulas, and packaging is compliant in all markets, as overseeing registration of new product launches in all global markets. Product quality will also fall under this role and will require working with contract manufacturers, ingredient and packaging suppliers as well as ensuring all product quality is up to company and industry standard. This role will report into the VP of Innovation and Product at K18.

Responsibilities

• Owns the regulatory function for K18. Maintains knowledge of regulatory compliance considerations and assures that all products comply with regulatory guidelines.
• Qualifies all proposed new ingredients by ensuring compliance in all planned territories of launch.
• Works with ingredient suppliers to gather all necessary safety/efficacy documents and compliance paperwork. Keeps ingredient document database organized and up-to-date.
• Ensures final formulas are compliant and creates/maintains master formula documents. Responsible for managing all master formula updates and change control.
• Works with outside regulatory agency and in-house legal as needed to qualify proposed marketing copy/claims. Keeps track of feedback and changes to claims/copy as needed. Maintains approved claims database.
• Helps review all product label artwork to ensure compliance in US, EU and other regions as needed.
• Manages relationships with third party regulatory and compliance groups for new product registrations which includes formula and label reviews, and communication of any necessary changes to K18 team.
• Coordinates procurement of notarized, Apostilled and/or legalized GMP Certificates, Certificates of Free Sale, and other documents as needed for global distributors.
• Vendor quality audits as needed as a function of regulatory requirements.
• Manages all third part certifications including leaping bunny, vegan, halal, and kosher.
• Manages K18 Plastic Bank workstream and ensure all documentation is tracked.
• Manages all Regulatory workstreams for new regions and continuous changes current regions in which K18 is sold. Some examples are MOCRA within the US, State Regulations pertaining to packaging, and EU Regulations around sustainability.
• Manages all product quality from product technical transfer, 3PL quality audits and managments, formula and packaging quality documents and specifications.

Skills & Qualifications

• At least 4+ years in a regulatory role in the personal care/cosmetic industry
• Bachelor's degree from an accredited university required.
• Master's degree preferred.
• Experience in product quality
• Knowledge of current US, EU, UK, and Canada regulations
• Experience with Cosmos (EU registrations) and Health Canada notifications
• Experience registering and launching in international markets, e.g. Asia (including China), Middle East, and parts of Latam
• Experience with manufacturer and other supplier audits
• Knowledge of cosmetic ingredients and the various documents needed to ensure safety/compliance
• Experience with OTC cosmetic products
• Ability to manage new ingredient compliance workstreams in partnership with ingredient vendor
• Highly organized with exceptional attention to detail with ability work in a fast paced environment

Salary Range: Up to $115,000 - $135,000 annually depending on experience

This range represents the low and high end of the anticipated base salary range for this position. The actual base salary will depend on numerous factors such as: experience, knowledge and skills, and if the location of the job changes.

EEO Statement

K18 is proud to be an equal opportunity employer and is committed to providing employment opportunities regardless of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, pregnancy, childbirth and breastfeeding, age, sexual orientation, military or veteran status, or any other protected classification, in accordance with applicable federal, state, and local laws. For more information, please see Know Your Rights: Workplace Discrimination is Illegal.

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