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Role Summary

• Reporting to a regional Regulatory Head, the Regulatory Manager is responsible for contributing to the development and implementation of compliance policies, processes and programs for the country business, which in the US, it consists of cosmetics, medical devices, dietary supplements, electrical products, medicines, and/or household consumer chemical products.

• The position will primarily focus on Cosmetic products and will work closely with the regional Regulatory Head to ensure appropriate communication, escalation, and prioritization of issues. This position is responsible for influencing Marketing, Sales, Quality, Legal, Supply Chain and R&D leaders to support identified improvements, as well as culture changes, to ensure an appropriate level of compliance risk within the business. This position also has regulatory oversight of new product launches in their country which includes review, approval and release to market new products, and any changes throughout the product lifecycle. This position is responsible for supporting regulatory inspections/audits and ensuring compliance of product realization.

Strategy and Functional Expertise

• Knowledge of policies, procedures and metrics
• Standard computer-based software knowledge
• Keeps accurate documentation and submits detailed reports to appropriate executives
• High attention to detail, organization and accuracy

Leadership and Influence

• Well organized and demonstrates forward leaning and high initiative
• Ability to influence cross functionally to deliver against business goals and objectives
• Manages strategic programs focused on meeting regulatory company requirements
• Manages and develops other members of the team
• Mentors others in technical areas of expertise
• Demonstrates broad business orientation
• Shows personal commitment to the vision and creates energy and optimism

Program Development/Program Management

• Confirms and/or improves processes to ensure they are being followed
• Monitors project progress and sets deadlines and budgets
• Solves issues quickly and efficiently
• Ensures stakeholder satisfaction
• Delivers project tasks on time
• Works cross-functionally to identify and communicate regulatory requirements
• Works cross-functionally to influence others to align with new requirements
• Oversees implementation to ensure adherence to new requirements
• Monitors spend and identifies additional project needs
• Evaluates project performance
• Has ability to prioritize and handle multiple projects simultaneously
• Communicates and engages appropriately with regulators and customers
• Conducts sensitive conversations in a confidential manner with consultants/regulators
• Maintains sensitivity of communication with internal and external entities (e.g. stakeholders, regulators, trade associations)
• Monitors progress by maintaining dialogue on work and results
• Makes good and timely decisions that keep the organization moving forward

Impact/Reach

• Strong execution skills
• Demonstrates agility and connectivity across the organization
• Actively builds connections and partnerships with others, internally and externally
• Ability to work with all levels of PD, Supply Chain and Technology teams to build relationships across functions

Education and Experience

• University degree from an accredited institution in a related field
• 8 years or more of technical Regulatory experience supporting cosmetic products and other FDA regulated products with a demonstrated track record
• Subject matter expert in US regulatory requirements for cosmetic products, including state-specific requirements and CPSC requirements. A plus will be if person has US regulatory experience with dietary supplements as well.
• Contributions focused on some strategic initiative as well as functional execution elements; works independently and manages people
• Consulted internally as an expert in US cosmetic regulations

Skills and Competencies

• Practical understanding, interpretation, and application of US FDA regulatory requirements for Cosmetic products, including understanding of CPSC requirements and state-specific requirements.
• While not required, it will be a plus if the person has practical understanding, interpretation, and application of US FDA regulatory requirements for Dietary Supplements.
• Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
• Ability to prioritize and to handle multiple projects simultaneously.
• Ability to work with all levels of management and to build relationships across disciplines.
• Excellent influence, persuasion, communication, and presentation skills

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Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

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