Regulatory Senior Specialist

Church & Dwight Co., Inc.•Princeton, NJ

7d•$92,500 - $131,700•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

Bachelor's degree in Science or a related field from an accredited institution.
Typically 5 plus years of technical Regulatory experience with a demonstrated track record.
Expertise 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.
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.
Ability to prioritize and handle multiple projects simultaneously.
Demonstrates agility and connectivity across the organization.
Ability to work with all levels of R&D, Marketing, Legal, Supply Chain, Technology teams to build relationships across functions.
Strategic and creative problem-solving skills.
Strong analytical skills.
Good oral and written communication skills.
Team-minded, detail-oriented, proactive self-starter.

Nice To Haves

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

Responsibilities

Manage tasks to support regulatory processes and projects leading to the commercialization of OTC drug and cosmetic products across multiple business units.
Carry out technical regulatory reviews, regulatory analyses and assessments.
Prepare regulatory summaries, make conclusions, and develop recommendations.
Present findings and recommendations to cross-functional teams.
Conduct product label reviews and assessments.
Manage product listings with FDA and facility registrations.
Work with cross-functional partners in R&D, Quality, Legal, Marketing, and Supply Chain.
Ensure 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.
Ensure knowledge of relevant State consumer product regulations, including the California Safe Cosmetics Program (CSCP).
Perform proficiency in consumer product label reviews for cosmetics and OTC drugs.
Perform proficiency in product and facility registration and listing processes, including FDA Cosmetics Direct, CSCP, OTC Drug listings and reporting.
Execute relevant policies, procedures, and metrics.
Maintain standard computer-based software knowledge.
Ensure accurate documentation and submission of detailed reports.
Demonstrate high attention to detail, organization, and accuracy.
Influence cross-functionally to deliver against project goals and objectives.
Be well organized and demonstrate forward-leaning and high initiative.
Deliver project tasks on time.
Work cross-functionally to identify and communicate regulatory requirements, regulatory risks and mitigation strategies.
Test, confirm and/or improve processes.
Solve issues quickly and efficiently.
Prioritize and handle multiple projects simultaneously.
Demonstrate agility and connectivity across the organization.
Actively build connections and partnerships with others, internally and externally.
Work with all levels of R&D, Marketing, Legal, Supply Chain, Technology teams to build relationships across functions.