Regulatory Affairs Manager (Remote)

Job Description

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Role Summary:

• Reporting to the regional Regulatory Head, the Regulatory Manager is responsible for contributing to the development and implementation of compliance policies, processes and programs for the US business, consisting of cosmetics, medical devices, dietary supplements, electrical products, medicines, and/or household consumer chemical products. The position will report and 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 the US, 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 and certification audits and ensuring compliance of product realization. 

• The focus of this role will be on EPA-regulated, household care products, but can also support other products as assigned.  This manager will provide subject matter expertise on EPA regulations, advise and guide the regional team on regulatory requirements for the introduction to market of a number of EPA-regulated products, and will be responsible for gaining product registrations and EPA and state reporting.

Skills and Competencies Required:

Strategy and Functional Expertise

• Manages strategic programs focused on meeting regulatory and company requirements
• Practical understanding, interpretation, and application of Federal and state Regulatory requirements (EPA, CPSC, states) for household products.  Understanding of FDA regulations as it relates to other product categories (cosmetics, OTC drug products) is a plus.
• High attention to detail, organization and accuracy with ability to integrate knowledge and leverage expertise to provide sound recommendations
• Knowledge of policies, procedures and metrics
• Keeps accurate documentation and submits detailed reports to appropriate executives
   

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 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

• Standard computer-based software knowledge
• 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
• Has ability to prioritize and handle multiple projects simultaneously
• Works cross-functionally to identify and communicate regulatory requirements and to influence alignment of others to work needed to meet new regulatory requirements
• Oversees implementation to ensure adherence to new regulatory requirements
• Monitors spend and identifies additional project needs
• Evaluates project performance: 
  • Makes good and timely decisions that keep the organization moving forward
  • Strong execution skills
  • Able to work in fast-paced environment, independently and without much assistance from management team
     

Communication:

• 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
• Communicates clearly 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)
• Communicates effectively with project teams to understand needs and provide solutions
• Monitors progress by maintaining dialogue on work and results
• Excellent presentation skills
   

Collaboration:

• Ability to collaborate successfully in a dynamic and culturally diverse workplace
• 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 and management to build relationships across disciplines.

Education and Experience Required:                                                          

• Bachelor or Master degree in a scientific discipline or equivalent is required.
• Minimum 8 years regulatory experience, with at least 5 years technical experience in obtaining regulatory registrations for EPA-regulated products, and in federal and state regulatory requirements for household consumer chemical products, including antimicrobial/pesticides.
• Knowledge of the US regulatory environment/framework for FDA-regulated consumer products (cosmetics, OTC drug products) is a plus, but not a requirement.
• Experience in Regulatory authority submission writing and review is required.

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

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/