Sr. Product Safety Specialist, Regulated Applications Job Job at Arkema

Arkema King of Prussia, PA 19406

Arkema has established itself as France’s leading chemical producer and a world leader in specialty chemicals and advanced materials. With annual sales of €8.8 billion and 20,000 people employed in some 55 countries, the Group pursues ambitious recruitment objectives both in France and around the world. Arkema offers diverse employment opportunities in 200 job functions and professions in four major fields: industrial, R&D, business, and support functions.

Reaching far beyond your discoveries!

Regarded as one of the world’s leading innovators, Arkema has made research one of the pillars of its strategy. For example by discovering new solutions to help reduce the weight of materials, hence cut down consumption. By developing innovative thermal insulation systems that can optimize the energy performance of buildings. Or by seeking new applications for its biosourced products at the service of greater sustainable development.

Innovative and durable solutions

Our high performance products have applications in wide-ranging areas, from new generation car batteries or telephones to recyclable wind turbine blades, from adhesives for the protective backsheets of solar panels to drinking water filtration systems, from running shoes and acrylic resins with no solvent and no volatile organic compound for 3D printing to molecular sieves for portable oxygen devices used by people suffering from respiratory failure… Joining Arkema means being part of a Group enjoying sustained growth that in little more than a decade has built up an exemplary achievement record, setting high ambitions for itself and for its employees. All our job opportunities are open to people with disabilities at equal merit or with equal skill levels.

Senior Product Safety Specialist, Regulated Applications


Location:
King of Prussia - Hybrid/Remote


Provides regulatory and technical support, guidance, and expertise to the Arkema Group business units, operating locations, staff groups and company facilities regarding HES and product safety regulatory matters at the product level for specially regulated applications, food processing and packaging, drugs, medical device, and pesticide/antimicrobial applications.

  • Perform product opinion reviews and/or Food Contact Notifications (FCN) submission packages for FDA, MERCOSUR, Health Canada (HC) food contact applications working directly with R&D and the Business Units. 35%
  • Manage filing and updates of Functional Additives Drug Master Files; submitting letters of access or obtain government certifications as necessary. In addition, provide good manufacturing practices regulatory guidance and support at appropriate manufacturing facilities.10%
  • Oversee Arkema NSF registration and audit compliance program. 2.5%
  • Complete reports, submit registration packages, and manage notification of change requirements for all business units to assure compliance with federal and state pesticide and antimicrobial registrations and establishment reporting. 10%
  • Manage company annual report and filing required under CWC, DEA, FIFRA, Facility registration or other compliance matters as required. 10%
  • Maintain updated regulation data for company’s database and customer letter application (e.g., RegAll) of product regulatory information. 10%
  • Provide sound technical solutions to regulated application (eg. CWC, DEA, FDA, USDA and FIFRA) compliance issues by maintaining a working knowledge of related regulations, and adapting to changes in the regulatory environment, specific state requirements, or unclear or inconsistent interpretations by governmental agencies. 10%
  • Manage the FSMA compliance requirements for the Arkema food facilities, distributors, and trans loaders. 10%
  • Perform all other duties as specified by supervisor. 2.5%


Qualifications:

  • B.S. Degree in relevant field of study (e.g., environmental science, biology, chemical engineering, chemistry, toxicology) or equivalent and minimum of 5 years’ experience in a product safety/regulatory affairs or related area.
  • A knowledge of relevant federal and state laws and regulations governing product safety including FIFRA and FDA, as well as knowledge of product risk management is essential.
  • Must have good interpersonal and written and oral communication skills, and capable of interacting with diverse groups at all technical levels such as customer service, plant personnel, R&D, customers, technical consultants, contractors, etc.
  • This position requires the job holder to be able to accomplish assignments, goals, objectives, and projects in an accurate and timely manner.
  • Current proficiency in standard office software (i.e., word processing, spreadsheet, database, and presentation packages) required.
  • This position must provide these services in the most cost effective means possible to meet key business objectives and maintain compliance with regulatory requirements for protection of human health and the environment.
  • Strong interpersonal, written and oral communication skills are required.
  • Experience successfully interacting with diverse groups at all technical levels such as customer service, plant personnel, R&D, customers, technical consultants, contractors, etc.
  • Ability to accomplish assignments, goals, objectives and projects in an accurate and timely manner with minimal supervision.
  • Travel 10%


A designer of materials and innovative solutions, Arkema shapes materials and creates new uses that accelerate customer performance. Our balanced business portfolio spans high-performance materials, industrial specialties and coating solutions. Our globally recognized brands are ranked among the leaders in the markets we serve. Reporting annual sales of €8.8 billion ($10.4 billion USD) in 2018, we employ approximately 20,000 people worldwide and operate in close to 55 countries. We are committed to active engagement with all our stakeholders. Our research centers in North America, France and Asia concentrate on advances in bio-based products, new energies, water management, electronic solutions, lightweight materials and design, home efficiency and insulation.

Arkema Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Arkema Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence.




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