Regulatory Affairs Specialist
Company: Intercos
Location: Congers
Posted on: May 9, 2022
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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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