JOB SUMMARY
This position involves various duties to support, maintain, and ensure regulatory compliance for an OTC and personal care/cosmetic manufacturing facility.
ESSENTIAL JOB FUNCTIONS

• Review/approve product labels and maintain label approval processes/procedures. 
• Assist with supplier, ingredient, and packaging qualification activities.
• Assist with Adverse Event/Serious Adverse Event management and reporting.
• Assist with the onboarding and regulatory review of new or reformulated products, including composition and ingredient declarations, Product Safety Reports, Wercs registration, and SDS authoring.
• Review website, social media, and promotional materials for claims and FTC compliance.
• Assist with compliance paperwork and regulatory submissions for international sales.
• Assist with FDA Establishment Listings, Drug Listings, Cosmetic Listings, Annual Certifications, and Annual Drug distribution reporting.
• Assist with FDA inspections.
• Author, review, and update Standard Operating Procedures (SOPs), forms and other documents.
• Provide backup to the Compliance Specialist

COMPETENCIES

• Ability to work with multiple departments and guide projects and teams.
• Excellent verbal and written communication skills.
• Strong attention to detail and high degree of accuracy.
• Able to read and interpret FDA guidances, OTC monographs, MoCRA and other applicable laws and regulations.
• Able to read, record, speak, and interpret documents in the English language.
• Computer and keyboarding skills with proficiency in Microsoft Office.

 
SUPERVISORY RESPONSIBILITY

• There are no supervisory responsibilities for this position.

WORK ENVIRONMENT

• This job operates in a professional office environment.  The role routinely uses standard office equipment such as computers, phones, photocopiers, scanner, filing cabinets and fax machines.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.

• The employee is occasionally required to sit, stoop, kneel, crouch or stand for periods of time.  The employee must occasionally lift and/or move up to 25 pounds. 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
USUAL WORKING HOURS

• Monday – Friday, 8:00 a.m. to 5:00 p.m.
• Capability to work extended hours if necessary.

TRAVEL

• This position may be required to travel for educational purposes.

REQUIRED EDUCATION/EXPERIENCE

• Bachelor of Science (BS) in a scientific or other relevant field.
• At least 2-3 years of experience in the regulatory or compliance field within the pharmaceutical or cosmetic manufacturing industry or alike. 
• Experience in regulatory reporting or other detailed reporting activities.
• Experience in label review or other detailed review activities.

EEO STATEMENT
PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
OTHER DUTIES
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice.