Sr. Regulatory Affairs Specialist
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.
Provide U.S. Regulatory direction and support for brands from concept to launch. Act as liaison between company and domestic regulatory authorities (e.g. FDA, EPA, CPSC), and provide regulatory feedback on potential new products. Lead in the development of any regulatory training required for 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.
Role Accountabilities and Responsibilities
- Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions to meet scheduling timelines and/or in resolving technical issues.
- Support product development initiatives from conception, through development, evaluation, pre-launch, launch, and post-launch.
- Collect and analyze data in support of regulatory submissions to health agencies.
- 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.
- Support departments such as sales and marketing, customer service, logistics, legal, IP, pipeline teams with requested information/queries.
- Support state manufacture/distribution licenses activities.
- Assist in the development of departmental SOPs as required.
- 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.
Education and Experience
- Bachelor’s degree in scientific discipline from an accredited institution.
- Prior experience in preparing and submitting Regulatory submissions (e.g. PMA, 510(k), ANDA, NDA etc.) and renewals.
- Ability to consistently deliver quality work in a high-pressure environment.
- Knowledge of submission processes and product life cycle management activities for various consumer product categories.
- Understanding of global product development practice, regulations and guidelines.
- Seasoned regulatory professional with 5-7 years’ experience in a regulatory affairs function with preferably, 3 to 5 years’ experience related to products similar to those of the Company.
Skills and Competencies
- 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
- Excellent communication skills for presenting to regulatory agencies and management team
- Well organized, articulate, self-starter, responsive and team player
COVID VACCINE REQUIREMENT*: To support the health and safety of our team members, successful candidates for employment in this role must (1) be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and to have submitted proof of vaccination status, or (2) request and receive an approved accommodation based on medical circumstances or sincerely held religious beliefs, practices or observances.
*Only applicable for Corporate positions based in Princeton, NJ and Ewing, NJ
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
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