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Regulatory Affairs Specialist
Ref No.: 18-37625
Location: New Albany, Ohio
Position Type:Direct Placement
Pay Rate : $ 55,000.00 /Year
Skill Type
Skill Type:Engineering
Job Summary:
The Regulatory Affairs Specialist provides regulatory support both domestically and internationally (US, Canada, EU & other regions) and ensures policies, procedures, and processes are in compliance with all applicable regulated requirements. This position works closely with customers and internal departments to prepare and maintain regulatory submissions for new products, product changes, as required to ensure continued compliance, and timely approval for market release of products.

Essential Job Functions:
  • Organizes and maintains regulatory files and databases to ensure prompt and accurate access to regulatory information for raw materials and formulas.
  • Reviews and confirms formula acceptability in accordance to the guidelines set by the applicable countries and/or customers.
  • Reviews and/or creates formula listings, ingredient lists, and other regulatory documents.
  • Requests and reviews supporting technical and non-technical data from raw material vendors.
  • Develops a regulatory compliance process that focuses on internal controls, process efficiency and standardization, and product integrity.
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
  • Provides regulatory guidance to product development teams and responds to product information requests
  • Provides marketing team with regulatory support in developing product profiles, ensuring claims are appropriate for cosmetics, and can be supported by formula.
  • Ensures that regulatory requirements are met for products prior to presenting to customers for submission and/or presentation.
  • Prepares and submits Equivalent Raw Material Forms.
  • Obtains and maintains relevant regulatory subscriptions, including PCPC, FDA, Cosmetic Design, etc.
  • Develops and/or updates Standard Operating Procedures (SOPs), policies, and other materials related to regulatory compliance. Documents and communicates any new or updated materials to all affected departments to ensure related databases are accurate and up-to-date.
  • Participates in team meetings related to regulatory compliance across the CLIENT network.
  • Performs other duties as assigned.

Education & Experience:
  • Bachelor of Science Degree in Chemistry or other related field. In lieu of degree, a combination of education and experience in the cosmetics/personal care industry considered.
  • Minimum of two years in a regulatory role required, preferably in the cosmetic/personal care industry.

Knowledge, Skills & Abilities:
  • Strong oral and written communication skills, interpersonal skills, and organizational skills.
  • Self-starter with strong work ethic, positive attitude, and excellent attention to detail.
  • Ability to perform multiple tasks simultaneously, manage competing priorities and time efficiently and effectively in a fast-paced environment.
  • Ability to promote and participate in a team-oriented and collaborative environment.
  • Ability to execute independent judgement on the compliance of any given product.
  • Strong computer skills, including Microsoft Office and Optiva.
  • Good understanding of FDA Good Manufacturing Practices Regulations (GMP's) and OSHA safety requirements.

Minimum Requirements:
  • Must be 18 years or older.
  • Able to work beyond normal work hours to complete assignments as required.
  • Read, comprehend, and follow written and verbal instructions, including SOPs.

Working Conditions:
  • Good working conditions; climate controlled.
  • Exposure to frequent movement of motorized equipment, including electric pallet jacks, forklifts, etc. while traveling throughout the facility.
  • Wear hairnet, safety glasses, long pants, steel toe shoes/boots and any other uniform standards as required.
  • Sit at computer for long periods of time.

This above Job Description is not intended to be an all-encompassing list of responsibilities, skills, efforts, or working conditions associated with this position. It is intended to be a guideline reflecting the principle activities.

I do hereby certify that I have read and do understand the above job description. I also understand and agree that CLIENT has the right to change or otherwise modify this job description at any time.

Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.