Position Title: Senior Manager International Regulatory
Affairs – Church & Dwight – Princeton, NJ
Department: Corporate Quality; Location: Princeton, New Jersey; Area of Interest: Regulatory
Affairs
Position Description:
We currently have an excellent opportunity for a Senior Manager – International Regulatory
Affairs located at our Princeton NJ headquarters.
Develop and execute regulatory strategy for the development and marketing of Church & Dwight
products intended for export from the United States (US). Oversight of regulatory strategy and
activity for Church & Dwight subsidiary developed products.
Role Accountabilities and Responsibilities
• Develop and execute the International regulatory strategy for US developed products (nonmedical device) intended for international markets. Partner with US Regulatory, as needed.
• Execute the regulatory strategy for US developed medical devices intended for international
markets.
• Direct and execute regulatory strategy using subsidiary resources to understand specific market
requirements.
• Oversee the regulatory strategy for locally developed products.
• Develop network of local market experts to advise regulatory execution for new product
categories or markets
• Provide direction to Research & Development (R&D), New Product Development (NPD), and
Marketing on International requirements to be incorporated in the development of products.
Provide long term solution options to effectuate timely inputs into the development process.
• Execute the assembly of common technical documents/ product information packages that
support the registration of US developed products in International markets. Provide long term
solution options to aid in the automated assembly of such information.
• Oversight of certificate of free sale/certificate of export program for US developed products.
• Execute development of global product registration database to manage future registration
obligations.
• Manage contact and budgetary information for the use of regulatory local market
experts/consultants.
• In partnership with subsidiaries or local market experts, evaluate new international regulatory
issues/requirements and communicate impact to relevant groups within C&D. Provide solution
options to address new regulatory issues.
• Facilitate timely resolution of product issues having a international regulatory perspective
through relevant C&D groups, subsidiaries, and/or local market experts.
• Provide support to US regulatory for FDA filings of new medical devices/in-vitro diagnostics
including 510k development.
Education and Experience
• Bachelor’s degree in scientific discipline from an accredited institution.
• Five (5) or more years’ experience in regulatory affairs function and preferably, 3 to 5 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) with demonstrated excellence.
Skills and Competencies
• Experience in solving complex problems.
• Ability to work in fast-paced environment.
• Well organized, articulate a self-starter, responsive and a team player.
• Ability to supervise 2 – 3 individuals to facilitate day to day regulatory operations.
• Capability to deal with multinational personnel to effectuate solutions.