Regulatory Affairs Specialist
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.
Bachelor’s degree with Major in Chemistry or life science is preferred.
Knowledge of FDA regulations for food, drugs and cosmetics.
Knowledge of Global Cosmetic regulation & GMPs.
- 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
- 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