Associate Manager, Regulatory Affairs - Colgate-Palmolive
Piscataway, NJ
About the Job
No Relocation Assistance Offered
Job Number #164383 - Piscataway, New Jersey, United States
Who We Are
Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
Scope:
The Regulatory Affairs Associate Manager supports Colgate’s Oral Care and Personal Care divisions. This position involves engaging in regulatory activities necessary for the maintenance of existing
products as well as the development and introduction of new products for the U.S and Canada markets. Additionally, this position may support projects for the Home Care category as needed.
Key Responsibilities
● Implement regulatory strategies and compliance activities for various product categories, including cosmetics, drugs, and medical devices, ensuring adherence to applicable U.S. FDA and Health Canada regulations.
● Manage regulatory activities to ensure compliance with FDA’s Modernization of Cosmetic Regulatory Act (MoCRA).
● Work closely with other functions to gather necessary information required for different regulatory submissions, including product and site registrations, notifications, renewals, and drug volume reporting.
● Prepare regulatory submissions to the FDA and Health Canada (e.g. Cosmetic Notifications, CBE, PAS, 510(k), NDA, ANDA, DIN and NHP).
● Collaborate with the cross-functional teams to support process improvement and new product development projects.
● Monitor and interpret evolving regulatory requirements, policies, and guidelines, and assess potential impact and prepare communications to internal stakeholders.
● Monitor federal and state restrictions for Chemicals of High Concern and assess impact to Colgate products.
● Collaborate with Product Safety and I&S on projects related to raw material compliance.
● Review and approve change controls and Tech Transfer checklists to assess the scope/impact of the changes and to recommend the appropriate implementation plan.
● Review, update and write Work Instructions and SOPs to capture processes and best practices to ensure compliance.
● Approve ingredients, recipes, labeling and specifications for new and existing products, ensuring compliance with all applicable requirements.
Required Qualifications
● Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
● Minimum 5 years of experience in regulatory affairs within the consumer goods or pharmaceutical industry.
● Comprehensive knowledge of U.S and Canada regulations pertaining to cosmetics and drugs.
● Proven experience in preparing and submitting regulatory documents.
Preferred Qualifications
● Experience supporting Product Safety and reviewing Chemicals of High Concern.
● Knowledge of U.S. and Canada medical device regulations and experience supporting
regulatory activities for medical devices.
● Experience using SAP and other regulatory software.
● Strong analytical skills and attention to detail.
● Excellent oral and written communication skills.
● Ability to work effectively in a cross-functional team environment.
● Strong project management skills with the ability to manage multiple projects simultaneously
● Proficiency in Google Workspace Suite.
Travel Requirements:
● Expected percentage of travel: 0 - 10 %
Compensation and Benefits
Salary Range $114.000,00 - $123.000,00 USD
Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles.
Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies.
Our Commitment to Diversity, Equity & Inclusion
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form (https://docs.google.com/forms/d/e/1FAIpQLSdaxk_eF4utznQoVHlxmL9jVFJbOkM4Oe5CAdKOg-h9EPdLfg/viewform) should you require accommodation.
For additional Colgate terms and conditions, please click here (https://www.colgatepalmolive.com/content/dam/cp-sites/corporate/corporate/en_us/corp/locale-assets/pdf/colgate-terms-and-conditions-2023.pdf) .
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Job Number #164383 - Piscataway, New Jersey, United States
Who We Are
Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
Scope:
The Regulatory Affairs Associate Manager supports Colgate’s Oral Care and Personal Care divisions. This position involves engaging in regulatory activities necessary for the maintenance of existing
products as well as the development and introduction of new products for the U.S and Canada markets. Additionally, this position may support projects for the Home Care category as needed.
Key Responsibilities
● Implement regulatory strategies and compliance activities for various product categories, including cosmetics, drugs, and medical devices, ensuring adherence to applicable U.S. FDA and Health Canada regulations.
● Manage regulatory activities to ensure compliance with FDA’s Modernization of Cosmetic Regulatory Act (MoCRA).
● Work closely with other functions to gather necessary information required for different regulatory submissions, including product and site registrations, notifications, renewals, and drug volume reporting.
● Prepare regulatory submissions to the FDA and Health Canada (e.g. Cosmetic Notifications, CBE, PAS, 510(k), NDA, ANDA, DIN and NHP).
● Collaborate with the cross-functional teams to support process improvement and new product development projects.
● Monitor and interpret evolving regulatory requirements, policies, and guidelines, and assess potential impact and prepare communications to internal stakeholders.
● Monitor federal and state restrictions for Chemicals of High Concern and assess impact to Colgate products.
● Collaborate with Product Safety and I&S on projects related to raw material compliance.
● Review and approve change controls and Tech Transfer checklists to assess the scope/impact of the changes and to recommend the appropriate implementation plan.
● Review, update and write Work Instructions and SOPs to capture processes and best practices to ensure compliance.
● Approve ingredients, recipes, labeling and specifications for new and existing products, ensuring compliance with all applicable requirements.
Required Qualifications
● Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
● Minimum 5 years of experience in regulatory affairs within the consumer goods or pharmaceutical industry.
● Comprehensive knowledge of U.S and Canada regulations pertaining to cosmetics and drugs.
● Proven experience in preparing and submitting regulatory documents.
Preferred Qualifications
● Experience supporting Product Safety and reviewing Chemicals of High Concern.
● Knowledge of U.S. and Canada medical device regulations and experience supporting
regulatory activities for medical devices.
● Experience using SAP and other regulatory software.
● Strong analytical skills and attention to detail.
● Excellent oral and written communication skills.
● Ability to work effectively in a cross-functional team environment.
● Strong project management skills with the ability to manage multiple projects simultaneously
● Proficiency in Google Workspace Suite.
Travel Requirements:
● Expected percentage of travel: 0 - 10 %
Compensation and Benefits
Salary Range $114.000,00 - $123.000,00 USD
Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles.
Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies.
Our Commitment to Diversity, Equity & Inclusion
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form (https://docs.google.com/forms/d/e/1FAIpQLSdaxk_eF4utznQoVHlxmL9jVFJbOkM4Oe5CAdKOg-h9EPdLfg/viewform) should you require accommodation.
For additional Colgate terms and conditions, please click here (https://www.colgatepalmolive.com/content/dam/cp-sites/corporate/corporate/en_us/corp/locale-assets/pdf/colgate-terms-and-conditions-2023.pdf) .
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Source : Colgate-Palmolive