POSITION PURPOSE (RESPONSIBILITY)

– Provide direct World Wide Regulatory support to various projects and products; supports strategic planning and product development efforts; and supports regulatory registrations, supports customer requests providing information on formulation, ingredients, IL’s, black lists,etc.      

ESSENTIAL FUNCTIONS AND BASIC DUTIES

– Provide Regulatory support for new and existing products with respect to product changes/modifications, labeling and promotional material review and approval.

– Maintains and updates customer’s black list, verifies the formulation for compliance with customer’s restrictions, provides regulatory reviews for use of certain ingredients in their formula,

– Reviews labeling and labels for compliance on different regions of the world (according with customers’ demand).

– Represents Regulatory Affairs on R&D product development teams to ensure all regulatory requirements are met throughout the development process.

– Under supervision, write, coordinate and complete Submission s for Regulatory Agencies (e.g. FDA, HC, TGA, EU, PMDA, CHN, etc.).  

– Complete Regulatory Assessments as needed and any other activities as assigned by Supervisor including special projects, as needed.

– Work with Intercos Customer Service, Marketing, Technical, Operations, Quality, and Customers.

– Participate in regulatory audits.

– Occasional travel may be required.

QUALIFICATIONS

Education/Certification:

Bachelor’s degree with Major in Chemistry or life science is preferred.

Required Knowledge:

Knowledge of FDA regulations for food, drugs and cosmetics.

Knowledge of Global Cosmetic regulation & GMPs.

Experience Required:

• Minimum of 3 to 5 years experience working in a Regulatory Affairs and/or Compliance capacity or equivalent related experience
• Experience in Global regulatory environment.
• Experience working with formulation and ingredients, knowledge of raw ingredients used in cosmetics
• Knowledge of pigments, colorants and pearls and associated restrictions for use in cosmetics for different areas of face/skin
• Maintain a clear product data file completed, ready to be use when necessary
• Proven experience working with the FDA-regulated products (previous FDA interaction is a plus)
• Experience in supporting/participating in regulatory audits.
• Experience in generating /reviewing product specifications, product certificates, Ingredient List (IL), QQs, PIFs, SDS, etc.
• Familiar to PCPC organization and cosmetic industry

Skills/Abilities:

• Good organizational skills. Good analytical thinking, problem solving and investigative skills required.
• Excellent communication skills (e.g. written, email, phone, etc).
• Strong technical writing skills.
• Knowledge of Formulator’s software and SAP (easy to learn)
• Can manage and maintain projects and timelines efficiently

Job Type: Full-time