Regulatory Senior Specialist

Church & Dwight • Princeton, NJ

5d • Remote

About The Position

Church & Dwight is seeking a Regulatory Senior Specialist to join their team. This role is responsible for managing tasks to support regulatory processes and projects leading to the commercialization of OTC drug and cosmetic products across multiple business units. The Regulatory Senior Specialist may lead medium-complexity projects or an appropriate scope project area. This position carries out technical regulatory reviews, regulatory analyses and assessments, prepares regulatory summaries, makes conclusions, develops recommendations, and presents to cross-functional teams in support of a varied number of initiatives. Tasks will also include product label reviews and assessments, product listings with FDA, and facility registrations. This position works with cross-functional partners in R&D, Quality, Legal, Marketing, and Supply Chain.

Requirements

• Knowledge of FDA and CPSC regulations and general regulatory requirements related to products in the Health, Personal and Beauty Care categories, including OTC drug products and cosmetic products.
• Knowledge of relevant State consumer product regulations, including the California Safe Cosmetics Program (CSCP).
• Proficiency in consumer product label reviews for cosmetics and OTC drugs.
• Proficiency in product and facility registration and listing processes, including FDA Cosmetics Direct, CSCP, OTC Drug listings and reporting.
• Knowledge and execution of relevant policies, procedures, and metrics.
• Standard computer-based software knowledge.
• Accurate documentation and submission of detailed reports.
• High attention to detail, organization, and accuracy.
• Ability to influence cross-functionally to deliver against project goals and objectives.
• Well organized and demonstrates forward-leaning and high initiative.
• Delivers project tasks on time.
• Bachelor's degree in Science or a related field from an accredited institution.
• Professional typically with 5 plus years of technical Regulatory experience with a demonstrated track record.
• Expertise required in regulatory requirements pertaining to OTC drug products and cosmetic products.
• Knowledge of CPSC-regulated products and CPSC regulations.
• Knowledge of state-specific requirements for OTC drug products and cosmetic products.
• Microsoft Office Suite.

Nice To Haves

• Knowledge of FDA requirements for other product categories in the Health Care space, such as dietary supplements, is a plus.
• Experience with dietary supplements.
• Experience with AI tools or AI-enabled ways of working.

Responsibilities

• Manages tasks to support regulatory processes and projects leading to the commercialization of OTC drug and cosmetic products across multiple business units.
• Carries out technical regulatory reviews, regulatory analyses and assessments.
• Prepares regulatory summaries, makes conclusions, and develops recommendations.
• Presents to cross-functional teams in support of a varied number of initiatives.
• Conducts product label reviews and assessments.
• Manages product listings with FDA and facility registrations.
• Works with cross-functional partners in R&D, Quality, Legal, Marketing, and Supply Chain.
• Identifies and communicates regulatory requirements, regulatory risks, and mitigation strategies.
• Tests, confirms, and/or improves processes.
• Solves issues quickly and efficiently.
• Prioritizes and handles multiple projects simultaneously.
• Demonstrates agility and connectivity across the organization.
• Actively builds connections and partnerships with others, internally and externally.
• Works with all levels of R&D, Marketing, Legal, Supply Chain, and Technology teams to build relationships across functions.

Benefits

• Medical, dental, vision, basic life insurance, paid vacation and sick time, and Paid Parental Leave.
• Paid holidays, floating holidays, and vacation days starting in their first year of employment depending on hire date.
• 401k retirement plan (with company match and profit-sharing).
• Discounted Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior