If you’re a high-energy, ambitious leader in your profession, we want to speak with you! Our Philosophy is simple. Image Now. Age later™.

Image Skincare is an evidence-based clinical skin care company, providing professional skincare products and effective skincare solutions in over 60 countries worldwide. The most innovative brand in the industry, Image Skincare consistently produces the latest anti-aging, balancing, hydrating, and illuminating technologies to further our mission of helping the world to Age Later™

Job purpose

As a key member of the Quality Assurance and Regulatory Affairs team, the incumbent will be responsible for conducting risk assessments in support of regulatory submissions and document management as follows

• Prepare safety assessments and human health risk assessments of cosmetics and consumer healthcare products;
• Prepare requisite product submissions (cosmetic, OTC drug and dietary supplements) to Regulatory Agencies and/or Ministries of Health;
• Support global market expansion through early identification of ingredient issues
•  Ensure regulatory compliance for all product labeling and promotional material including internet copy.

 

Duties and responsibilities

New Product Development and Product Life Cycle Maintenance

• §  Participate in the New Product Development (NPD) process leading the assessment of product formulations for ingredient compliance with restricted/banned substance lists and flag these to the NPD team;
• §  Work with NPD on life cycle maintenance for existing products flagging ingredients that may have issues related to human and/or environmental safety, proposing alternatives whenever possible;
• §  Maintain currency on global ingredient issues and partner with Marketing and Education in developing company positions and/or draft ingredient safety point-of- view documentation;
• §  Prepare safety assessments and human health risk assessments of Image cosmetics and OTC drug products related to non-conforming ingredient and/or product issues;
• §  Identify requisite safety testing in order to substantiate product claims both on labeling and in training material;
• §  Prepare regulatory submissions to US state agencies requiring information on marketed products.

International Market Expansion and Compliance

• §  Contribute to regulatory activities required to obtain, prepare and submit requisite documentation for cosmetic product notification to the Image Skincare EU Representative;
• §  Prepare INCI labeling for Global compliance;
• §  Prepare regulatory documentation and manage the notification process for dietary supplement products across the globe;
• §  Support international growth by obtaining/preparing the requisite documentation for product registrations/notifications and throughout the regulatory life cycle management process;
• §  Review all product labeling and promotional material for compliance with applicable standards and regulations;
• §  Prepare and submit OTC drug submissions and cosmetic product notifications to Health Canada;
• §  Prepare Drug Fact Box content for OTC labeling in the US and Canada;

 

 

Qualifications

• §  Bachelor’s degree in a scientific discipline. DABT certification desirable.
• §  3 - 5 years of experience in the pharmaceutical, personal care, dietary supplement or medical device industry;
• §  Working knowledge of OTC drug, cosmetic and dietary supplement regulations in the US and Canada
• §  Working knowledge of State of California regulations pertaining to ingredients and implementation of Safe Cosmetics Act and subsequent regulations pertaining to cosmetics;
• §  Working knowledge of the EU Cosmetic Regulation and Notification Process and other global cosmetic regulations, e.g. AESAN Directive;
• §  Ability to summarize technical data and prepare regulatory submissions, documents and reports;
• §  Experience using an electronic document management system for the storage of regulatory documents, reports and other technical information
• §  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.

Working conditions

 

Same as for QA & RA team including:

§  Flexible hours and adaptability

§  Some travel if needed to visit with CMOs, and/or assist with special events such as brand sponsored events, trade shows, community events, employee-related events and fundraising functions

 Benefits Available:

6 Paid Holidays

Medical, Dental, Vision and Life Insurance (after 30 days of employment)

401 (k) (after one year of service)

Employee Corporate Discount Program

PTO (Paid Time Off)