Director, Product Safety and Regulatory Affairs
Situation in organization
Reports to Vice President, Manufacturing & Regulatory Affairs.
Ensure that the Product Safety and Regulatory Affairs Group maintains the necessary skills and provides the necessary services to the company in order to satisfy the product safety regulatory obligations and activities of Arkema, Inc. The Group 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. Ensure that the appropriate product safety measures are included and addressed for major capital and expense projects. Administer the toxicology program and spending in a fiscally responsible and technically competent manner that results in effective management of the product safety risks and liabilities for the corporation and that preserves and enhances shareholder value.
- Direct a corporate staff of 22 individuals including mostly highly skilled technical personnel such as chemists, biologists, and toxicologists with 10 to 20+ years experience. The annual budget for the Product Safety and Regulatory Affairs Group is approximately $4.7M.
Key Activities and responsibilities
-Create and implement goals, strategies, objectives and key performance indicators for product safety & regulatory affairs that will support the achievement of both long and short-term corporate goals and business objectives of the company and will lead to the transformation of Arkema Inc. Product Safety and Regulatory Affairs activities into best in class in the chemical industry. (25%)
- Develop options, formulate solutions and execute plans to solve highly complex product safety regulatory issues in a sustainable, sound, safe, efficient, and cost-effective manner. (20%)
- Counsel and advise all levels of management in the areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication) product regulatory affairs, product stewardship and product risk management. Maintain a thorough knowledge of emerging regulatory issues, innovative technologies and technical expertise providers to ensure that the projects are cost effective and dynamic. (20%)
- Coordinate implementation of global product safety regulations and corporate initiatives as they impact Arkema Inc. Identify and promote sustainable development/green chemistry innovative ideas, best practices and business process improvements across the Arkema organization. (10%)
- Direct, train, motivate, and lead a productive and technically competent team of professionals responsible for product safety and toxicology and regulatory compliance activities company-wide. (15%)
- Lead the development and implementation of appropriate product safety and regulatory affairs training programs for the company’s corporate and manufacturing personnel. (5%)
- Manage Product Safety and Regulatory Affairs budget and administration. (5%)
Context and environment
Ensuring that the Company’s products comply with product safety and regulatory affairs 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. Further, product risk management and sustainability issues must often address concerns of numerous internal and external stakeholders with diverse interests, including differing country and state regulatory agencies, public interest groups, customers, business units, operating facilities. If regulatory compliance and product safety risk 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 maintain an effective product safety and regulatory affairs group, the position must be able to define and carry out practical technical and strategic approaches which 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
Required Education/Qualifications /Work experience
This is an upper middle management position in the company that requires strong leadership, organizational, communication and interpersonal skills.
- Minimum of 15-20 years’ experience in the product safety/products risk liability profession with training in law, toxicology, chemistry, or an equivalent education. Ten (10) or more years of that experience in the chemical industry would be desirable.
- Strong background in problem solving, negotiations and project management is required.
- Must be a strategic thinker with strong analytical and decision-making capabilities with an ability to function effectively in high-pressure situations.
- A detailed working knowledge of relevant federal and state laws and regulations governing product safety such as TSCA, FIFRA, FDA, OSHA Hazard Communications as well as knowledge of product risk management and product stewardship is essential.
- Must have the ability to identify and fully understand the potential products safety and product risk management liabilities associated with acquisitions and divestitures, and must be able to quantify the potential risks.
Demonstrated Competencies (Describe behaviors necessary for role)
- Must be able to motivate and manage (or coordinate) teams from different cultures, countries, or hierarchies.
- Excellent interpersonal and communication skills are required. Must be capable of interacting with diverse groups at all technical levels such as regulatory agencies, other industries, community groups, technical consultants and contractors, engineers, attorneys, customers, etc.
Building on its unique set of expertise in materials science, Arkema offers a portfolio of first-class technologies to address ever-growing demand for new and sustainable materials. With the ambition to become in 2024 a pure player in Specialty Materials, the Group is structured into three complementary, resilient and highly innovative segments dedicated to Specialty Materials - Adhesive Solutions, Advanced Materials, and Coating Solutions - accounting for some 80% of Group sales, and a well-positioned and competitive Intermediates segment. Arkema offers cutting-edge technological solutions to meet the challenges of, among other things, new energies, access to water, recycling, urbanization and mobility, and fosters a permanent dialogue with all its stakeholders. The Group reported sales of €8.7 billion ($9.7 billion) in 2019, and operates in 55 countries with 20,500 employees worldwide.
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.
Toxicology, Genetics, Regulatory Affairs, Manager, Law, Science, Legal, Management