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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.

The Role

The Regulatory Affairs Manager provides Regulatory strategy and direction from product concept to launch through the product lifecycle, with emphasis on OTC drug products, homeopathic products but also supporting other products such as cosmetics as assigned. Provides subject matter expertise on OTC drug products and homeopathic products; advises and guides the regional and global cross-functional teams on regulatory requirements for market introduction and maintenance. Provides technical mentorship to junior team members within and outside Global Regulatory Affairs. Serves as a lead technical interface for the department. Acts a key liaison between the Company and regulatory approval authorities (e.g., US FDA).

Manager Responsibilities:

  • Lead product development initiatives from conception, through development, evaluation, pre-launch, launch, and post-launch.
  • Identify regulatory requirements and optional pathways to market.
  • Provide regulatory information, guidance and strategy for product development and planning throughout the product lifecycle.
  • Evaluate regulatory impact of proposed changes to marketed products and communicate clear actions.
  • Monitor and communicate regulatory intelligence to assist in the development of business and compliance plans.
  • Provide regulatory information and guidance for proposed product claims and labeling. Approve product artwork and promotional materials.
  • Lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation and implementation of new internal policies and procedures. Assist other departments to develop SOPs as needed to ensure regulatory compliance.
  • Simplify regulatory information and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • Represent Regulatory function in external and internal inspections (FDA).
  • Ensure all assigned records to support inspections are established, maintained and documented.
  • Perform other duties as assigned.
  • May have direct reports.

 

 

Qualifications, knowledge, training or experience required for the post.

  • Bachelor’s or Master’s degree in a scientific discipline or equivalent is required.
  • Minimum 8 years regulatory experience, with at least 5 years technical experience in assessing regulatory suitability of OTC drug and homeopathic products for the US market, including development of label/artwork and review of advertising/marketing claims.
  • Experience in managing and supporting other FDA-regulated products such as cosmetics or dietary supplements is a plus.
  • Excellent influence, persuasion, verbal and written communication skills.
  • Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
  • Individuals must demonstrate the ability to collaborate successfully in a dynamic and culturally diverse workplace.
  • Ability to consistently deliver quality work in a high-pressure environment.
  • Excellence in solving complex problems, project strategy, execution, and collaboration skills.
  • Comfort and skill to work in fast-paced environment, independently and without much assistance from management team.

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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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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 for accessibility to the online application system, the interview process, completing any pre-employment testing, or any other portion of application process, as a result of impairment from a medical or mental health condition, they may contact 877-809-8449 or email their resume and cover letter to jobs@churchdwight.com.     

To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.

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