Cosmetic Regulatory Compliance Coordinator

Scope:

The Regulatory Compliance Specialist will provide expertise and ensure compliance with US and international regulatory requirements to help bring projects to market through collaboration with Sales, Marketing, Purchasing, Quality and Product Development and support market expansion by submission of regulatory applications to domestic and international agencies.

Responsibilities:

• Develop and maintain systems, policies and procedures to ensure Regulatory Compliance to Food and Drug Administration (FDA) and European Union (EU) cosmetic regulations, ECOCERT COSMOS-standard Organic and Natural standard and the Roundtable on Sustainable Palm Oil (RSPO) standard.
• Prepare renewal and inspection documentation and facilitate on-site or remote regulatory and third-party certification audits (COSMOS, RSPO, FDA, etc.).
• Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for us and global markets, providing guidance in interpreting regulations and agency guidelines; briefing management on issues that may impact manufacturing operations, product formulations, claims or packaging compliance.
• Organize, create, and prepare submissions to certifiers or regulatory bodies in support of new product development or new market opportunities internationally.
• Review raw material documentation for ongoing compliance, compliance in new markets, against new and emerging regulations, or in support of new product launches.
• Serve as the regulatory representative to provide technical expertise, risk assessments, and solutions for product development, product labeling and regulatory issues.
• Prepare Qualitative and Quantitative ingredient listings (ILS) from data received from vendors for ingredient review against US, and other international markets.
• Provide guidance on product labeling, ingredients and claims language regulations.
• Review labeling and marketing material for Food and Drug Administration (FDA), Federal Trade Commission (FTC), Prop 65, COSMOS and RSPO compliance.
• Conduct full regulatory review all product labeling for new products along with existing product labeling revisions to ensure compliance with applicable US/Global regulations and certification standard requirements.
• Facilitate necessary updates to existing product labeling, communicating required changes to the Graphic Design team via change control protocols.
• Initiate, review and maintain Change Control documentation and ensure compliance to protocol.
• Create and manage product dossiers by compiling raw material, component and formula specifications and required label information, including directions, warnings, ingredients list, allergen information, and marketing call-outs; revising as needed based on various changes, including formula updates, ingredient changes, marketing updates, etc.
• Perform other related duties as assigned by Management.

Qualifications:

• Knowledge of FDA Cosmetic Regulations including new requirements under the Modernization of Cosmetics Regulation Act (MoCRA); International Standards Organization (ISO) standards 9001:2015 and 22716:2007 and systems.
• Ability to demonstrate strong ownership of assigned projects and work independently, completing assigned tasks accurately, and on-time.
• Must be independent and self-motivated with the ability to work well within a team setting with cross-functional interaction with Sales, Operations, Quality and Supply Chain teams.
• Must possess exceptional oral and written communication and interpersonal skills, negotiation and problem resolution skills.
• Must have excellent computer skills (Microsoft Office, Excel, Word, etc.).
• Must be organized, detailed-oriented and have ability to handle multiple tasks at once and redirect focus based on company's needs.
• Must comply with internal protocols and Standard Operating Procedures (SOPs) as well as follow Good Manufacturing Practices (GMP).

Education/Experience:

Associates of Science Degree in relevant field of study or,

2+ years’ experience in cosmetics, or pharmaceutical manufacturing facility in a similar role.

Experience within a regulatory environment with focus on cosmetics, pharmaceutical, or food manufacturing a plus.

Knowledge of regulatory frameworks in Personal Care, Cosmetics, Pharmaceutical, Food or Beverage industries.

Combination of education and/or work experience.

Come join the CST team as the Regulatory Compliance Coordinator and contribute to the success of our organization by ensuring that we operate within legal and ethical boundaries. Apply today!

Job Type: Full-time

Pay: $60,000.00 - $68,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• Monday to Friday

Ability to Relocate:

• Fall River, MA 02721: Relocate before starting work (Required)

Work Location: Hybrid remote in Fall River, MA 02721