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Regulatory Affairs Specialist

Company: Intercos
Location: Congers
Posted on: May 9, 2022

Job Description:

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

Keywords: Intercos, Yonkers , Regulatory Affairs Specialist, Other , Congers, New York

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