No Relocation Assistance Offered
Job Number #164383 - Piscataway, New Jersey, United States
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
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