Regulatory Senior Specialist

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Job Summary

Church & Dwight is seeking a Regulatory Senior Specialist to join our 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.

About the Role

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.

Work Environment 

Remote: This role is performed on a remote basis and is open to candidates located anywhere in the United States who are able to work within the Eastern Time Zone (EST) business hours. Occasional attendance at in-person meetings may be required as business needs dictate.

Role Accountabilities and Responsibilities

• The Senior Regulatory Specialist manages tasks to support regulatory processes and projects leading to the commercialization of OTC drug and cosmetic products across multiple business units. This role

• 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

• Works cross-functionally to identify and communicate regulatory requirements, regulatory risks and mitigation strategies

• Tests, confirms and/or improves processes

• Solves issues quickly and efficiently

• Ability to prioritize and handle multiple projects simultaneously

• Demonstrates agility and connectivity across the organization

• Actively builds connections and partnerships with others, internally and externally

• Ability to work with all levels of R&D, Marketing, Legal, Supply Chain, Technology teams to build relationships across functions

Skills and Competencies

• Strategic and creative problem-solving skills
• Strong analytical skills
• Good oral and written communication skills
• Team-minded, detail-oriented, proactive self-starter

Education and Experience       

Required Qualifications: 

• 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
• Senior Specialist knowledge/expertise: 
  • 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
  • Knowledge of FDA requirements for other product categories in the Health Care space, such as dietary supplements, is a plus.

Preferred Qualifications:

• Experience with dietary supplements.
• Experience with AI tools or AI-enabled ways of working.
• Microsoft Office Suite.

Compensation and Benefits

The U.S. base salary range for this full-time position is $92,500– $131,700. This position is also eligible for a bonus. 

As a Church & Dwight US employee, you (and eligible dependents, as applicable) will have access to medical, dental, vision, basic life insurance, paid vacation and sick time, and Paid Parental Leave. U.S. employees are entitled to paid holidays, floating holidays, and vacation days starting in their first year of employment depending on hire date. You are also able to participate in our 401k retirement plan (with company match and profit-sharing) and Discounted Employee Stock Purchase Plan.   

The actual base pay offered to the successful candidate will be based on multiple factors, including, but not limited to, job-related knowledge/skills, experience, business needs, geographical location, and internal pay parity.  Compensation decisions are dependent upon the facts and circumstances of each position and candidate. 

#LI-Remote 

Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

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