Global Regulatory Science (GRS) completes critical studies to assess the safety and global registrability of discovery candidates, develop and register new active ingredients, enable regional expansion of new end-uses for registered active ingredients, and defend existing commercial products worldwide. GRS completes GLP-compliant studies through a solid knowledge of globally-accepted study protocols in the areas of metabolism, residues, e-fate, mammalian toxicology, eco-toxicology, human exposure and safety and non-target risk.
The Director of Global Regulatory Sciences (GRS) is a cross functional role that interacts between three FMC organizations; Global Regulatory Affairs for product registrations and safety studies, Research and Development for new product growth, and the Regional businesses for product sustainability. The Director has experience seeing and critically evaluating opportunities and creating a strategy and plan and creating buy-in for the vision to the broad business team, acquiring adequate staying power to accomplish the strategy, and then putting in place the resources and processes to drive execution of the plan.
The Director of GRS provides strategy, direction on execution of that strategy to drive GRS priorities, manages GRS work load and resources through the GRS Managers, assures effective teamwork between GRS and multiple teams: R&D science teams for Discovery, Plant Health, Investigative Sciences, Formulations, Analytical, and Sample Supply as well as scientific support to Global Regulatory Affairs, Product/Project Management, and all regional business Registrations teams.
- Continue to ensure future alignment of GRS to be competitive, developing strategic approach for resource allocation (e.g., budget, staffing, study placement), balancing short- and long-term demands to deliver the greatest business value. [defining goal & setting priorities in context of business, regulatory, external/internal value – i.e., cost/benefit]
- Provide oversight, challenge and ensure organizations are aligned on the strategies to defend FMC’s assets globally.
- Effectively collaborate with key stakeholders and tailor communication of GRS business value to audience, maintaining principles that guide prioritization.
- Identify and evaluate new requests from regions to define a coordinated, consistent and strategic approach, effectively managing organizational and financial resources.
- Drive organizations to ensure regulatory timelines are met to protect FMC’s Right to Operate.
- Anticipate and evaluate resource needs and adjust accordingly based on the estimated peaks and valleys of work from the EU (majority of work; via data compiled by GRA Competitive Intelligence) and regions (via Planishare).
- Enable identification and implementation of improvements and innovation in processes and collaboration across GRA, GRS, R&D and other organizations to ensure optimal organizational effectiveness.
- Reinforce and assure consistent adherence to FMC’s processes, SOPs, ethics and compliance.
- Accountable for ensuring GRS budgeting and forecasting of out of pocket spend meets FMC financial targets. Drives financial awareness and responsibility to all staff. Provides leadership to ensure that all project plans are consistent with the regulatory science strategy and that the work is accurately budgeted. Works closely with R&D Project Management Director, to monitor the financial spend and make critical decisions on regulatory studies timing in order to meet financial targets.
Pipeline and Product Support:
Ensures clear and proactive communication to the business of the risks and/or opportunities for GRS studies, waivers, and risk assessments for active ingredient defense with study costs, timing, and probability for approval using assessment of regulatory science requirements and potential outcomes.
PHD or equivalent in related science
Job qualifications include but are not limited to the following:
- Experience managing a diverse multi-functional, globally-distributed team, with expert knowledge in several scientific and regulatory disciplines required to support global pesticide registrations under European Commission 1107/2009, USEPA FIFRA, and OECD processes.
- Strong communication skills with people at all levels of the organization and from diverse backgrounds and cultures. Comfortable working with senior management, peers, subordinates, and prominent scientists and influential people outside FMC in both science and regulatory arenas.
- In-depth technical experience is required in global pesticide regulations, creative and strategic problem-solving, and insights and long-term view of regulatory and science trends with ability, flexibility, and courage to create and drive changes in anticipation of future business barriers.
- Strong leadership experience to build a collaborative, effective organization that
- fosters learning and knowledge sharing
- empowers group managers to seek and develop creative solutions within regulations and compliance
- influences others
- takes initiative while delegating to empower colleagues and
- drives accountability to deliver high quality results that exceed expectations.
- Excellent organizational, verbal and written communication skills
- Business acumen with a proven record managing across a matrixed organization is required. Understands business drivers/imperatives, the competitive situation, and what is required for programs to be successful and how GRS can contribute to and even transform the business.