Carma Laboratories
Job Details
Job Location Corporate Office - Franklin, WI
Position Type Full Time
Education Level 4 Year Degree
Job Shift Day
Job Category Manufacturing
Description
Position Summary:
The Regulatory Affairs Assistant Manager ensures global compliance with cosmetic and OTC drug regulations by leading and supporting regulatory affairs activities at Carma Laboratories. Collaborating closely with their supervisor, this role implements regulatory strategies, supports product registrations, and drives process improvements to maintain both current and future compliance. Additionally, the position develops and enforces processes and protocols to uphold strong regulatory practices throughout the organization.
Reports to: Manager Regulatory Affairs
Functional Responsibilities: Assists with FDA and global regulatory compliance tasks, while supporting general quality system initiatives such as QMS, audits, SOP development, and continuous improvement efforts. Acts as a global regulatory liaison supporting in-market representatives, guided by the Regulatory Manager. Collaborates with cross-functional teams to research and complete detailed regulatory tasks for new and existing products and communicates requirements clearly to colleagues. Supports supervisor and assists with monitoring and interpreting global chemical and packaging compliance & sustainability regulations and domestic state-based EPR requirements. Assist with international cosmetic/OTC product registrations and dossier preparation & compilation under the Regulatory Manager's guidance. Supports prompt facility registration(s) and listing(s) for all US OTC drugs and cosmetics. Works with supervisor to research and interpret Canadian Regulations and manage the preparation and submission of Canadian Cosmetic Notification Forms (CNFs) to Health Canada, ensuring all required product information-such as ingredients, concentrations, and intended use-is accurately reported for compliance. Stays abreast of REACH law Regulations to ensure compliance with current EU chemical regulations, including substance registration and safety requirements, and communicates with Only Representatives (ORs) to coordinate regulatory submissions and maintain up-to-date compliance documentation. Assist the Regulatory Manager with marketing materials, product claims, and labeling to ensure regulatory compliance with all products. Manage compliance with the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (CFFIRKA) Ensure products are retailer compliant by monitoring and interpreting global retailer-specific regulations and actively working within WERCSmart and Smarter Sorting platforms. Works with supervisor to interpret evolving raw material and packaging material compliance requirements in all markets. Maintains and enters updates in Carma Labs internal regulatory database to ensure that information is current with a focus on continuous improvement and process efficiencies. Reviews global regulations and guidance and collaborates with supervisors and cross-functional teams to ensure regulatory compliance of ingredients, formulations, and packaging materials for both new and existing products. Prepares and manages product dossiers ensuring pertinent files (toxicological testing, claims testing, consumer testing) are appropriately and accurately filed to ensure cGMP compliance and address potential legal or audit inquiries. Collaborate with supervisor to provide global regulatory compliance strategies for both short- and long-term business planning. Provide support for the global consumer complaint and monitoring process. Required Experience, Desired Skills & Qualifications:
Minimum 7 years' experience in a regulatory CPG and/or OTC drug role Has experience collaborating on the development of global regulatory strategies. Thorough understanding of current Good Manufacturing Practices (cGMPs) Practical experience and expertise in ensuring compliance with U.S. FDA regulations for OTC drug products, including adherence to applicable FDA monographs. Experience supporting FDA inspections, including preparation, facilitating audits, and addressing regulatory feedback. Has working knowledge of FDA regulations (OTC & cosmetic), Health Canada regulations, and EU regulations and guidelines. Hands-on experience with global product registrations and dossier preparation. Proficient in label and claims review processes. International regulatory experience preferred. Understanding of state regulatory agencies and requirements (e.g., Prop 65, EPR). Knowledge of EU regulations (e.g. REACH Law, Regulation (EC) No 1223/2009) Proven ability to work collaboratively within a cross-functional project team environment. Background in a manufacturing environment Proven ability in writing Standard Operating Procedures (SOPs) Excellent oral and written communication skills Open, honest communication skills Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, PowerPoint, Smartsheet) Ability to perform statistical evaluation and analysis of data Reasoning Ability:
Has the ability to define problems, collect data, establish facts, and draw valid conclusions in any situation. Has the ability to solve problems and deal with a variety of variables in situations where only limited information exists.
Educational Qualifications:
BS (or MS) in Chemistry, Biology and/or related discipline
Physical Requirements:
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is regularly required to sit; use hands, handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear.
The employee must be able to lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Employee must be able to sit for up to eight hours in a workday. Ability to function in highly demanding situations.
Environmental Requirements:
The work environments described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Job Location Corporate Office - Franklin, WI
Position Type Full Time
Education Level 4 Year Degree
Job Shift Day
Job Category Manufacturing
Description
Position Summary:
The Regulatory Affairs Assistant Manager ensures global compliance with cosmetic and OTC drug regulations by leading and supporting regulatory affairs activities at Carma Laboratories. Collaborating closely with their supervisor, this role implements regulatory strategies, supports product registrations, and drives process improvements to maintain both current and future compliance. Additionally, the position develops and enforces processes and protocols to uphold strong regulatory practices throughout the organization.
Reports to: Manager Regulatory Affairs
Functional Responsibilities: Assists with FDA and global regulatory compliance tasks, while supporting general quality system initiatives such as QMS, audits, SOP development, and continuous improvement efforts. Acts as a global regulatory liaison supporting in-market representatives, guided by the Regulatory Manager. Collaborates with cross-functional teams to research and complete detailed regulatory tasks for new and existing products and communicates requirements clearly to colleagues. Supports supervisor and assists with monitoring and interpreting global chemical and packaging compliance & sustainability regulations and domestic state-based EPR requirements. Assist with international cosmetic/OTC product registrations and dossier preparation & compilation under the Regulatory Manager's guidance. Supports prompt facility registration(s) and listing(s) for all US OTC drugs and cosmetics. Works with supervisor to research and interpret Canadian Regulations and manage the preparation and submission of Canadian Cosmetic Notification Forms (CNFs) to Health Canada, ensuring all required product information-such as ingredients, concentrations, and intended use-is accurately reported for compliance. Stays abreast of REACH law Regulations to ensure compliance with current EU chemical regulations, including substance registration and safety requirements, and communicates with Only Representatives (ORs) to coordinate regulatory submissions and maintain up-to-date compliance documentation. Assist the Regulatory Manager with marketing materials, product claims, and labeling to ensure regulatory compliance with all products. Manage compliance with the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (CFFIRKA) Ensure products are retailer compliant by monitoring and interpreting global retailer-specific regulations and actively working within WERCSmart and Smarter Sorting platforms. Works with supervisor to interpret evolving raw material and packaging material compliance requirements in all markets. Maintains and enters updates in Carma Labs internal regulatory database to ensure that information is current with a focus on continuous improvement and process efficiencies. Reviews global regulations and guidance and collaborates with supervisors and cross-functional teams to ensure regulatory compliance of ingredients, formulations, and packaging materials for both new and existing products. Prepares and manages product dossiers ensuring pertinent files (toxicological testing, claims testing, consumer testing) are appropriately and accurately filed to ensure cGMP compliance and address potential legal or audit inquiries. Collaborate with supervisor to provide global regulatory compliance strategies for both short- and long-term business planning. Provide support for the global consumer complaint and monitoring process. Required Experience, Desired Skills & Qualifications:
Minimum 7 years' experience in a regulatory CPG and/or OTC drug role Has experience collaborating on the development of global regulatory strategies. Thorough understanding of current Good Manufacturing Practices (cGMPs) Practical experience and expertise in ensuring compliance with U.S. FDA regulations for OTC drug products, including adherence to applicable FDA monographs. Experience supporting FDA inspections, including preparation, facilitating audits, and addressing regulatory feedback. Has working knowledge of FDA regulations (OTC & cosmetic), Health Canada regulations, and EU regulations and guidelines. Hands-on experience with global product registrations and dossier preparation. Proficient in label and claims review processes. International regulatory experience preferred. Understanding of state regulatory agencies and requirements (e.g., Prop 65, EPR). Knowledge of EU regulations (e.g. REACH Law, Regulation (EC) No 1223/2009) Proven ability to work collaboratively within a cross-functional project team environment. Background in a manufacturing environment Proven ability in writing Standard Operating Procedures (SOPs) Excellent oral and written communication skills Open, honest communication skills Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, PowerPoint, Smartsheet) Ability to perform statistical evaluation and analysis of data Reasoning Ability:
Has the ability to define problems, collect data, establish facts, and draw valid conclusions in any situation. Has the ability to solve problems and deal with a variety of variables in situations where only limited information exists.
Educational Qualifications:
BS (or MS) in Chemistry, Biology and/or related discipline
Physical Requirements:
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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is regularly required to sit; use hands, handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear.
The employee must be able to lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Employee must be able to sit for up to eight hours in a workday. Ability to function in highly demanding situations.
Environmental Requirements:
The work environments described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.