- Develop and implement product safety and regulatory affairs processes, programs, and systems (including, without limitation, composition databases, SDS and label systems, packaging programs, PMN processes, Drug Master Files, etc.) for the HPP business and ensure ongoing compliance with international, federal, state, local, and corporate product safety requirements for products within the HPP business. (20%)
- Counsel and advise the HPP business in areas of product safety (including TSCA, FIFRA, FDA, REACH, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of HPP products. Develop options, formulate solutions and provide guidance to execute plans and projects to solve product safety regulatory issues in a sustainable, sound, safe and cost-effective manner. (25%)
- Maintain a thorough knowledge of emerging technical and regulatory issues pertaining to the HPP business and their products. (10%)
- Effectively advocate the Company's product safety and product stewardship positions with trade associations, government agencies and non-governmental organizations. (10%)
- Manage the provision of timely and appropriate product safety and regulatory affairs responses to inquiries from customers, users, and agencies, and others regarding the HPP products. (15%)
- Advise and conduct training for the HPP research and development, commercial and manufacturing personnel, and customers on product safety and regulatory affairs issues related to the HPP products. (10%)
- Manage project budgets. Perform all other duties as specified by supervisor. (10%)
- B.S. Degree in relevant field of study (e.g. environmental science, biology, chemical engineering, chemistry, toxicology) and 10 years minimum industrial experience or MS degree in relevant field of study and 5 years minimum industrial experience.
- A detailed working knowledge of relevant federal and state laws and regulations governing product safety such as TSCA, FIFRA, FDA, OSHA Hazard Communications, hazardous materials transportation as well as knowledge of product risk management and product stewardship is essential.
- Current proficiency in standard office software (i.e., word processing, spreadsheet, database, and presentation packages), as well as the ability to learn specialized applications such as SAP and ARIEL, quickly is required.
- The job holder must have good interpersonal and written and oral communication skills, and must be capable of interacting with diverse groups at all technical levels such as regulatory agencies, other industry representatives, customers, technical consultants, contractors, engineers, attorneys, etc.
- The jobholder must be self-directed, with a strong background in problem solving and development of creative cost-effective solutions.
- Ability to concurrently lead and/or manage multiple complex projects in a fast paced and complex environment.
- Detail oriented, with excellent prioritization and follow-up.
- Ability to challenge and influence decision making to diverse groups at all technical levels such as regulatory agencies, other industry representatives, customers, technical consultants, contractors, engineers, attorneys, etc.
- Self-directed with strong analytical and problem solving skills.
- Ability to effectively navigate and work within in a global and culturally diverse environment.
- Effective leadership capable of managing and developing subject matter experts
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PS&RA Manager Job - King of Prussia, United States - Arkema
Description
The Corporate Product Safety and Regulatory Affairs team has an opening for a PS&RA Manager, responsible to support the High Performance Polymers (HPP) business unit. In conjunction with the HPP business for which this position is responsible, the PS&RA Manager manage activities to assure compliance with legal and corporate product safety and regulatory affairs requirements in a cost effective and efficient manner. Also responsible to manage two compliance and safety experts as well as consultants.
Reports to Sr. Manager, Product Safety and Regulatory Affairs.
Domestic travel, less than 15%
KEY ACTIVITIES:
QUALIFICATIONS:
COMPETENCIES:
