Regulatory Affairs Associate-International

US-NJ-Princeton
ID
2018-10565
Function
Regulatory Affairs
Department
Regulatory Affairs - Corporate

Overview

At Church & Dwight, we value talented professionals with a strong desire to make a positive impact in our company. We are looking for an ambitious and resourceful Regulatory Affairs Specialist whose action-oriented mindset will foster continued growth throughout our leading brands.

In this highly visible role located at our Global R&D Center in Princeton, NJ you will ossess and maintain up-to-date knowledge of regulatory requirements relative to products and areas of responsibility as assigned.

What you’ll do:

  • Maintains current knowledge of products and regulatory requirements affecting products. Prepares and authors regulatory submissions according to country registration requirements to facilitate product approvals
  • Provides critical review for regulatory compliance of product studies involving human subjects, the content and format of labeling and promotional materials, and other individual or on-going tasks as assigned in an organized, accurate, comprehensive, and timely manner.
  • Interface with applicable regulatory agencies and international consulates to prepare documentation for registration activities. Participates in regulatory agency audits and responses to support audit findings or other actions related to such audits as needed.
  • Requests, verifies, compiles and organizes product formula, information, and summary data in support of label and promotional claims, safety and effectiveness for internal documentation files and, when applicable, for submissions to government authorities for product marketing authorizations or information/data requests.
  • Interacts cooperatively and effectively with other departments within the company and work groups of trade associations as assigned in the preparation of regulatory documents and positions and the provision of regulatory advice.
  • Acts in concert with the company and departmental policies, positions and strategies, adapts well and promptly to changing priorities.
  • Provides periodic reports to keep the director informed of activities and status of projects.
  • Research and analyze International regulations impacting company portfolio of products.
  • Provide assistance for Notified Body regulatory audits.
  • Provides assistance to the managers and/or director as otherwise required.
  • Create, maintain, monitor and analyze master data in ERP and/or other integrated solutions in compliance with established service levels

What you’ll need:

  • Bachelor’s degree in a scientific discipline from an accredited institution or equivalent extensive work experience directly applicable to the position
  • 3 years’ experience in a regulatory affairs function, or five years’ experience in a closely related scientific function (e.g. quality assurance, quality control, research etc.) related to products similar to those of the company.
  • Experience working with GMP requirements, ISO standards, Knowledge of Health Canada, COFEPRIS, TGA, MDD, IVDD Requirements.

Church & Dwight is proud to be an Equal Opportunity Employer, m/f/d/v.

 

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

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