Senior Manager, Toxicology, Regulated Applications and Business Process Optimization |
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Reports to Senior Director, Industrial Safety & Product Safety/Regulatory Affairs
Manages Toxicology team (3 direct reports), Regulated Applications team (1 direct report and 1 indirect report), the Business Process Optimization and PS&RA Systems team (1 direct report and 1 indirect report and TSCA compliance (1 direct report and 1 indirect report) (total 9 reports).
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Job dimensions |
This position defines and implements the short and long-term Toxicology/Regulated Applications and Business Process Optimization strategies for Arkema Inc., Americas. The position establishes standards and compliance levels for these functions. This position is point of contact on the subject of toxicology and regulated applications, with specific focus and responsibility for Arkema, Inc. Americas.
- Direct a corporate staff of 9 toxicologists, toxicology specialists, regulatory experts (FDA, FIFRA, TSCA, CWC, DEA, etc), and IT/business process experts, including mostly highly skilled technical personnel such as toxicologists, chemists, and biologists, with 8 to +20 years' experience. The toxicology and regulated applications staff supports Arkema Inc. Americas BUs' toxicology and regulated application requirements and assures compliance with legal and corporate HES requirements in a cost effective and efficient manner. The BPO and PS&RA systems team drives continuous improvement by optimizing processes and systems, automating data gathering, reporting, and analysis for the Product Safety & Regulatory Affairs group.
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Key Activities and responsibilities
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Create goals, strategies, objectives and key performance indicators for toxicology, regulated applications and business process optimization that will support the achievement of long and short-term corporate goals and business objectives of the company.
- Identify and develop business/corporate strategies and initiatives to address emerging health and environmental issues as they apply to toxicology, ecotoxicology, and regulatory issues on a domestic and international scale. Maintain a knowledge of emerging toxicology, ecotoxicology, and regulatory issues pertaining to each BU and its products. Maintain leadership positions in effectively advocating the Company's product safety and product stewardship positions with customers, trade associations, government agencies and non-governmental organizations.
- Manage the development and implementation of toxicology, ecotoxicology, regulated application and TSCA compliance processes, programs, and systems (including, without limitation, toxicology, FDA, TSCA, FIFRA and other databases, PMN, FDA, FIFRA, TSCA and other processes, etc.) for all Arkema Inc., Americas Business Units (BUs), and ensure ongoing compliance with international, federal, state, local, and corporate toxicology, ecotoxicology and regulatory requirements. Develop options, formulate solutions and provide guidance to execute plans and projects to solve toxicology, ecotoxicology and regulatory issues in a sustainable, sound, safe and cost-effective manner.
- Lead development, optimization and implemention of product safety and regulatory affairs processes and systems including, without limitation, composition databases, SDS and label systems, packaging programs, raw material data management, PMN/FDA/SDS Workflows and other regulatory processes, to support efficient performance of PS&RA team activities.
- Lead the toxicology team, regulated applications team,TSCA complianceteam and BPO team including oversight and performance of the team members, determining staff requirements, managing personnel and budget preparation. Direct, train, motivate, and counsel toxicologists and regulated applications experts responsible for product safety and regulatory compliance activities related to the various Arkema Inc. BUs. Develop and manage project budgets.
- Lead toxicology, ecotoxicology and regulated application integration activities for corporate acquisitions and divestitures. Perform all other duties as assigned.
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Context and environment |
Ensuring that the Company's products comply with PSRA requirements is challenging and complex. Compliance with product safety regulations can be difficult since such regulations often differ from state to state and from country to country. If product safety regulatory compliance issues are not managed appropriately, the Company can be exposed to excessive expenditures and/or legal liability or be unable to sell its products. To achieve this, position must be able to define and carry out practical technical and strategic approaches that are dynamic and integrated with sound business management principles, fiscal responsibility, risk management techniques, and communications procedures.
- Supports the site HES policy and complies with all regulatory and internal requirements
- Participates in HES activities provided by site management and Arkema Inc. (e.g., Behavioral Base Safety, SafeStart, etc.)
- Supports and promotes the reporting of all health, safety, environmental, near-miss, accident or injury incidents
- Includes 10% domestic and 5% international travel
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Required Education/Qualifications /Work experience |
- PhD in Toxicology, Ecotoxicology, Pharmacology or related health or environmental science with a minimum of 15-20 years Toxicology experience in the chemical, pharmaceutical or petroleum refinery industry. DABT certification preferred.
- Thorough knowledge of US regulatory requirements related to toxicological and environmental fate and effects, hazard and risk assessment, notification obligations, established network with other industry, CRO and regulatory experts in the field.
- Experience managing a function and multiple employees and projects which may be delegated across other company functions is necessary.
- Must have comprehensive knowledge ofUS and international laws and regulations pertaining to specially regulated applications (TSCA, FDA, USDA and FIFRA).
- Must have experience with, and in-depth knowledge of, SAP EH&S software, and other database management systems necessary for Department operations.,
- Experience interacting with diverse groups at all technical levels such as regulatory agencies, other industry representatives, customers, technical consultants, contractors, engineers, attorneys, etc is required.
- Current proficiency in standard office software (i.e., word processing, spreadsheet, database, and presentation packages), as well as the ability to learn specialized applications quickly is required
- Should be a recognized as functional specialist in the company, and have visibility across all regions and all levels of the regional organization.
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Demonstrated Competencies |
- Excellent interpersonal, listening, written and oral communication and negotiating skills.
- 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 a strong analytical and problem solving skills and development of creative cost-effective solutions.
- Ability to accomplish assignments, goals, objectives and projects in a timely manner with minimal supervision or direction.
- 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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