Regulatory Affairs Specialist

Company Overview:
We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together!
In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.
Position Details:

• Title:Regulatory Affairs Specialist
• Ideal Candidate: The ideal candidate for this role will have 2-5 years Regulatory experience, preferably with a background in cosmetics.
• Schedule: 8:30 am - 5:00 pm, M-F. *This position is ONSITE in an office setting.
• Location: Gibbstown, NJ (08027)

Position Overview/Job Description:
The Regulatory Affairs Specialist is responsible for managing appropriate regulatory and technical information to ensure regulatory compliance and support product registrations globally. This individual must possess general knowledge of global regulatory requirements relative to cosmetic products and other areas of responsibility as assigned.
Essential Functions:

• Manage and support global registration of cosmetic products.
• Advise management on regulatory matters concerning cosmetic products and provide guidance for compliance to any new or updated regulations and requirements.
• Write, assemble, and maintain documentation and information to support compliance to regulatory requirements for products sold domestically and internationally.
• Write, assemble, and maintain technical documentation and information to support customer requests, including Safety Data Sheets, Ingredient Lists, Technical Data Sheets, and/or Company Statements.
• Maintain State and Federal product listings, registrations, licensing and establishment registrations.
• Support new product or reformulated product launches.
• Generate and maintain Product Information Files.
• Where required, coordinate safety assessments of cosmetic products with 3rd party vendors.
• Conduct product labeling and literature review to ensure labeling meets appropriate regulations of the country in which the product will be marketed in.
• Support handling of customer complaints. Document and communicate customer complaints with appropriate Regulatory personnel and notify competent authorities of events that have serious undesirable effects.
• Coordinate and support product recalls with Customers and/or competent authorities.
• Assist with external inspections and/or audits conducted by Regulatory Authorities or Customers.
• Assist with internal audits as assigned by the Quality Assurance department.
• Maintain appropriate documentation, procedures, and quality records.

Qualifications:

• 2 - 5 years relevant experience in a regulated technical function, preferably cosmetics
• Strong interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally.
• Adept verbal and written communication skills-including technical writing & documentation.
• Excellent organizational and project management skills with ability to track, prioritize, and organize multiple concurrent projects.
• High attention to detail.
• Strong problem solving and multi-tasking skills.

Desired Skills:

• Knowledge of cGMP requirements, ISO standards and/or quality assurance
• Familiarity with international market labeling and registrations
• Knowledge of REACH, OSHA, EU CLP, and GHS labelling and SDS requirements
• Experience using Intelligent Authoring (or similar service) for document generation

Education/Certifications:

• Bachelor's degree or equivalent, with a strong preference for chemistry or related field desirable

Safety:

• Complies with all safety regulations; always maintains a safe work environment.
• Adheres to always wearing the proper PPE/Safety equipment.
• Understands and complies with all written safety, health, and environmental procedures.
• Attends all required scheduled Health, Safety and Environmental training sessions.
• Participates in required Health, Safety and Environmental initiatives and programs.
• Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.

Benefits/Perks:

• Medical, RX, Dental, and Vision Plans
• Company-sponsored Life Insurance
• Flexible Spending Account (FSA) - Medical, Dependent Care, & Commuter
• 401K Plan with Employer Contribution
• Voluntary Term Life/AD&D Insurance, Short-Term and Long-Term Disability
• Accident and Critical Illness Insurance
• Pet Insurance
• Employee Assistance Program (EAP)
• Tuition Assistance Program
• Weekly Pay
• Paid Holidays
• Employee Referral Bonus Program
• Company social events throughout the year including tickets to sports events and concerts
• Free Lunch Daily (Gibbstown)
• On-site free Fitness Center with personal trainer (Gibbstown)
• Fitness Membership (Cherry Hill/Myerstown)