Company Description: World Product Solutions provides innovative world-class product formulation and manufacturing services. We specialize in custom formulation, manufacturing, and fulfillment services for various brands. Our approach ensures that each client's unique needs are met with high-quality solutions. With a commitment to excellence, we support brands in achieving their market goals effectively and efficiently.
Key Responsibilities:
· Prepares requisite submissions (cosmetic, OTC drug and dietary supplements) to Regulatory Agencies and/or Ministries of Health.
· Supports global market expansion through early identification of applicable product standards and regional and/or national regulatory requirements.
· Leads the development and execution of processes and procedures related to implantation of a 21CFR Part 11 compliant document management system (DMS).
· Ensures regulatory compliance with all product labeling and promotional material including internet copy.
· Maintains all certificates and business permits current.
· Helps with other Quality functions as assigned.
Skills and Experience:
· Working knowledge of OTC drug, cosmetic and dietary supplement regulations in the US and Canada.
· Working knowledge of the EU Cosmetic Regulation and Notification Process and other global cosmetic regulations, e.g. AESAN Directive.
· Experience developing and managing electronic DMS as it relates to cGMP compliance.
· Strong understanding of cGMP compliance regulations and ability to apply regulations consistently.
· Ability to summarize technical data and prepare regulatory submissions, documents, and reports.
· Excellent written and oral communication skills.
· Strong interpersonal skills that enable the incumbent to work effectively and in a collaborate manner across all Image teams in a very fast-paced environment.
· Agile and flexible in the ability to quickly accommodate changes in direction, product launches, retailer demands, consumer demands as well as the dynamic global regulatory landscape.
Education/Certifications:
· Bachelor’s degree in scientific discipline. RAPS certification is desirable.
Requirements:
2 - 5 years of experience in the pharmaceutical, personal care, dietary supplement or medical device industry.
World Product Solutions is an Equal Opportunity Employer and does not discriminate with regard to age, gender, race, nationality, religion, sexual orientation, disability or any other class protected by law. We offer a complete benefits package, casual working environment, and the ability for people to make a difference.
Job Type: Full-time
Pay: $50,000.00 - $55,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Vision insurance
Application Question(s):
- How many years of experience do you have in the pharmaceutical, personal care, or dietary supplement industry?
- How many years of experience do you have in Quality?
Ability to Commute:
- Oldsmar, FL 34677 (Required)
Work Location: In person