• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs • Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions • Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. • Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements • Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff

• WindBorne is looking for an ambitious Federal Compliance Lead to build our government compliance function from scratch and own it end-to-end. • You will be the first dedicated compliance hire, reporting to the COO and ensuring we don’t get bottlenecked as we scale into production government software sales. • You will lead the company through CMMC Level 2 certification, FedRAMP, IL5, and IL6, translating complex federal regulatory frameworks (FedRAMP, DoD CC SRG, CMMC, DFARS 7012) into practical decisions about technical architecture, documentation, and process. • Make sure those decisions actually get implemented by coordinating work across engineering, operations, and business development teams.

• Serve as a regulatory expert for registering products across crop protection, biologicals, and antimicrobials/biocides. • Collaborate closely with our local knoell USA team and our global network of experts to ensure seamless service delivery for our clients’ most critical registration and regulatory strategy projects. • Mentor other colleagues in developing regulatory expertise. • Provide support from data gap analysis to final label approval. • Direct the preparation, implementation, and coordination of regulatory projects for new product introductions and lifecycle maintenance across the U.S., as well as Canada and Mexico if your expertise supports. • Apply expert knowledge of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to register traditional actives and other relevant products. • Perform comprehensive data gap analyses, draft waiver requests, and design testing strategies to meet EPA and state-level requirements. • Draft and review regulatory labels including those for biological products, ensuring compliance with federal and state labeling laws. • Act as primary point of contact for the knoell team for North America expertise. • Provide expertise alongside project managers in client inquiries, proposals, and budget advising.

Role Description The role of Sr IT SOX Compliance Consultant would be cross functional through various business processes and support functions. It requires that you bring your inquisitiveness, sense of innovation and demonstrate your will and capability to learn new things. - Identifying improvement opportunities in SOX relevant areas, defining what those look like, analyze and work to bring it to fruition while defining appropriate controls as well. - Evaluating and ensuring IT processes are appropriately defined to ensure that financial statement risks are adequately mitigated while maintaining a holistic view. Designing, implementing, and testing IT controls. - Partner with business and utilize knowledge of IT and financial processes, financial reporting risk, and internal controls to design, evaluate, and monitor the Company’s internal IT controls. - Conducting IT & adjacent process walkthroughs to ensure control objectives are met and sufficient coverage is maintained. - Defining remediation processes and analyzing the extent of any control deficiencies and mitigation procedures from the management perspective. Advise and monitor process owners on action plans for remediation of deficient controls. - Working with cross functional teams to understand relevant controls and defining how they translate to the company. Work with the teams to clearly communicate intent and expectations of SOX controls and remediate any concerns. - Reviewing new projects on a periodic basis to determine SOX impact; for any new applications identified, help in the design of the relevant SOX controls. - Providing recommendations to business process teams on how to leverage technology for operational and SOX optimization. - Interfacing with management on all required activities and with Internal and External audit teams around SOX scoping and controls definition; provide reasonable support during the audit lifecycle. - Prepare clear and well-organized audit work papers that appropriately document the work performed and clearly outline work expected of others. - Supports IT Risk and Compliance Team with IT Change Management activities, validation activities, IT Audit and other related activities and processes. - Leads continual process improvements to IT Risk and Compliance policies, processes, procedures, and documentation. - Lead the development and implementation of IT Compliance trainings for the organization with the specific goal of establishing clear and well-understood expectations for SOX controls to control owners. Qualifications - 8+ years of experience in SOX audits/compliance roles. - 5+ years of experience in working on a major ERP (SAP/Oracle). - 8+ years of experience working on IT General/Application controls. - 3+ years of experience working in public accounting firms (Tier I/Tier II) preferred. - Experience auditing/building processes/working on end-to-end lifecycle of at least 1 common business process. - Effective Communication across all levels of the organization. - Ability to work independently with proper prioritization and organization to achieve promised timelines. - Ability to build relationships and collaborate as a team across all levels of the company to achieve the desired results. Benefits - Medical, dental, and vision care coverage. - Paid time off plan. - 401(k) Plan. - Flexible Spending Accounts. - Basic life insurance. - Short-and long-term disability coverage. - Accident insurance. - Teammate Assistance Program. - Paid parental leave. - Domestic partner benefits. - Mental, physical, and financial well-being programs.