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Principal Regulatory Affairs Specialist - Full Time Remote Options

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:

                                                          

Provide U.S. Regulatory expertise and direction in support of brands from concept to launch.  Develop strategy on complex technical projects.  Strategy includes liaising between company and domestic regulatory authorities (e.g. FDA, EPA, CPSC), providing feedback on potential new products, supporting acquisition actions including assisting management in due diligence review, and leading development of any training required in on-boarding activities for new employees.  Analyze emerging technologies with R&D, and support the consumer research group with study design in all brand areas.  Provide technical mentorship to junior team members.  Serve as a lead technical interface for the department.

Responsibilities:                                                       

  • Lead product development initiatives from conception, through development, evaluation, pre-launch, launch, and post-launch.
  • Develop regulatory strategy on complex, technical problems.
  • Collect and analyze data in support of regulatory submissions, draw conclusions, and make data-based recommendations to management or brand/R&D teams on regulatory pathways.
  • Support various product studies and consumer/clinical studies to gain critical consumer insights for product development and/or to gather/evaluate data in submission activities.
  • Review and write procedures and policies as needed.  Review specifications as necessary.
  • Act as liaison between Regulatory Affairs and other departments within the Company in support of brands, concept to launch.
  • Act as liaison with government agencies and trade associations on assigned projects in support of brands.
  • Review technical work and provide technical coaching/mentoring to junior team members.

Requirements:                                                          

  • Bachelor’s degree in scientific discipline from an accredited institution.
  • Highly seasoned regulatory professional with 5-7 years’ experience in a regulatory affairs function with demonstrated strategic capability and preferably, 3 to 5 years’ experience related to products similar to those of the Company.
  • Prior experience with Regulatory submissions (e.g. PMA, 510(k), ANDA, NDA etc.)

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/


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Research and Development

Innovate, Inspire, Collaborate across functions and Strive to make an impact. All in a day’s work in our R&D employees.

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Role Location

United States

With corporate offices and major plants across the country, we’re building consumer products and connecting with global offices from the place where it all began.

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DIVERSITY At Church & Dwight

Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.

We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.

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CULTURE At Church & Dwight

We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.

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Equal Employment Opportunity for the Disabled At Church & Dwight

As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to jobs@churchdwight.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to jobs@churchdwight.com or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.

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