Senior Regulatory Specialist 9/9/2016
EMD Performance Materials
JOB DESCRIPTIONAPPLY EMD Performance Materials Corp. currently has an opportunity for a Senior Regulatory Specialist---Cosmetics, Food and Sunscreens. The Senior Regulatory Specialist interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. This position has no direct reports. The majority of the work will be with Cosmetic ingredients, sunscreens / UV Filters, and food ingredients. The successful candidate must have significant experience in these areas.
This position in located in our Philadelphia, PA office.
The Senior Regulatory Specialist is responsible for the following:
* Assure US regulatory compliance for cosmetic ingredients, food colorants, food ingredients and sunscreen / UV filter ingredients are maintained.
* Review, comment and approve/disapprove change control requests which affect the marketing (labeling, website, brochures, advertising) of cosmetic ingredients, sunscreen ingredients, food ingredients and food colorant products in the US in accordance with US FDA standards and procedures.
* Maintain labeling information for all FDA products.
* Review all intended use and information supplied by Trade Compliance to FDA in the import process.
* Maintain database of cosmetic, food, sunscreen products and their intended uses
* Perform Regulatory Reviews of Formulas for Compliance with appropriate FDA regulations
* Obtain and maintain NDC Codes for sunscreen and other products
* Maintain information for all NDC registered products and supply to Trade Compliance as needed
* Develop and maintain a procedure for assignment, cancellation and previous used NDC codes
* Act as the US Agent for FSMA facilities.
* Submit registration for all facilities as required by FSMA.
* Work with domestic and international facilities to assure compliance with FSMA requirements in areas of Food Safety Plan, HARPC, and Food Defense Plans.
* Representing RA on project teams and providing regulatory guidance
* Representing EMD with regulatory agencies and industry groups as applicable
* Conduct risk assessments
* Establish yourself as a primary contact for regulatory decisions and interpretations of FDA topics
* Follow, interpret and report on developing US / Canada regulations
* Maintain regulatory standards and protocols to ensure compliance with various regulations.
* Perform literature searches and regulatory review of publications to assure up-to-date compliance with US and international regulations, and communicate findings to appropriate internal customers.
* Develops and manages systems for storage, retrieval, and documentation retention for regulatory documents
* Bachelors of Science Degree in the natural science; Masters preferred -
* This position will mainly operate in in regulations concerning cosmetics, food colorants, food ingredients and sunscreens. Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), Good Manufacturing Practices (GMP s), Food Safety Modernization Act (FSMA) and others as required.
* Knowledge in other US regulations such as FIFRA and TSCA, would be a plus.
* Strong interpersonal, communication and organizational skills.
* Detail-oriented and process driven.
* Aptitude to analyze and interpret FDA regulations and compliance standards.
* Experience in executing multiple projects simultaneously.
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.