Role Description The Director, Regulatory Affairs Operations is accountable for defining and executing the regulatory operations strategy for the organization. This role leads the operational infrastructure, processes, and systems that enable Regulatory Affairs to operate efficiently, compliantly, and at scale in a growing I&I biotechnology company. The Director ensures that global regulatory submissions are strategically planned, executed, tracked, and archived with precision. - Assessment, onboarding, oversight, and performance management of external regulatory operations vendors. - Ownership of the regulatory operations budget, in close partnership with IT, Quality, and the direct manager. - Optimizing the regulatory information management (RIM) ecosystem. - Establishing robust publishing and submission execution frameworks. - Ensuring inspection‑ready archival and traceability across the submission lifecycle. - Developing and implementing regulatory operations processes and training programs to support cross‑functional stakeholders. - Providing ongoing system and user support. - Ensuring cross‑functional alignment on regulatory timelines, milestones, and submission readiness. - Partnering extensively with enterprise functions including Regulatory Strategy, Clinical Development, Preclinical, Quality, Commercial, and IT. - Leading the development of an enterprise regulatory data model that enables seamless data flow, reuse, and traceability across programs and regions. - Building the foundation for a world‑class regulatory function capable of supporting Beeline Medicines’ growth and global ambitions. Qualifications - Bachelor's degree in life sciences, pharmacy, or a related field required; advanced degree preferred. - Minimum of 10 years of regulatory affairs experience in the pharmaceutical or biotech industry. - At least 3 years in a regulatory operations leadership role. - Demonstrated experience managing eCTD submissions and electronic publishing processes, including familiarity with FDA, EMA, and ICH eCTD technical specifications. - Hands-on experience with Regulatory Information Management (RIM) systems such as Veeva Vault Regulatory, PAREXEL's Liquent, InSight, EGNYTE or equivalent platforms. - Thorough knowledge of ICH CTD requirements, FDA 21 CFR Part 11, and applicable regulatory submission standards across clinical development phases. - Proven ability to manage complex submission timelines and cross-functional regulatory deliverables in a matrixed pharmaceutical or biotech environment. - Experience developing regulatory SOPs, training materials, and governance frameworks in compliance with international regulatory requirements. - Familiarity with Trial Master File (TMF) standards (DIA Reference Model) and inspection readiness practices. - Strong regulatory project management skills; experience with regulatory-specific project management tools and timeline visualization platforms is preferred. - Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities. - Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy. - Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners. Requirements - Define and lead the Regulatory Affairs Operations strategy, establishing scalable infrastructure, processes, and systems to enable efficient, compliant global Regulatory Affairs execution from IND through post‑approval. - Own end‑to‑end submission planning and execution, ensuring regulatory submissions are planned, built, validated, delivered, tracked, and archived with precision, including eCTD lifecycle management and Health Authority interactions. - Oversee the regulatory information management (RIM) ecosystem and enterprise regulatory data model, enabling seamless data flow, reuse, traceability, inspection readiness, and a complete, accessible, and user‑friendly regulatory archive. - Establish and manage the regulatory submission and publishing operating framework, defining standards for content creation, management, reuse, quality review, and archival across the full submission lifecycle. - Build and manage a high‑performing regulatory vendor ecosystem, defining outsourcing strategies, performing vendor assessment, onboarding, oversight, performance management. - Oversight of the regulatory operations budget ownership in partnership with IT, Quality, and leadership. - Develop regulatory operations processes, training, and user support models, driving adoption, consistency, and effective use of systems and workflows across internal teams and external partners. - Drive operational excellence and executive transparency, establishing KPIs, metrics, and risk management practices; conducting periodic quality assessments of the regulatory management system; and communicating submission readiness, risks, and operational insights to senior leadership. - Perform other duties and responsibilities as assigned. Benefits - Medical, Dental & Vision insurance (employee premiums 100% covered by company). - 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge. - Flexible work arrangements / hybrid schedule. - Health Savings Account (HSA).

• Provides oversight and manages the full lifecycle from customer applications through energization. • Serves as the central coordinator across engineering, construction, regulatory, and customer facing work streams to ensure compliant, efficient, and reliable integration of renewable generation onto the grid. • Overseas the interconnection application pipeline and drives projects through studies, agreements, and approvals on schedule. • Serves as primary point of contact for Commercial and Industrial interconnecting customers. • Lines engineering, compliance and construction teams with FERC, NERC, and state PUC requirements. • Tracks program health metrics and reports to leadership including power BI dashboards, and work trackers. • Supports business development by participating in project scoping, fee development, proposal preparation, interviews, negotiations, and contract development. • Reviews assigned project(s) after award to define project scope, determine work procedures/sequences and develops schedules, budgets, staffing, vendor lists and progress billing points. • Meets with client management as necessary during the term of a project to resolve issues and to obtain approvals at the project’s completion. • Maintains a continuing business relationship with clients as part of ongoing business development efforts. • Plans, organizes, communicates and coordinates project engagements. • Manages the day-to-day activities of project engagements including Clients and Project Teams. • Achieve project objectives including quality/scopes, budgets, and schedules. • Analyzes project performance and resource utilization. • Identifies potential out of scope work. • Manages, and negotiates contract change orders. • Identifies and manages project risk from the proposal phase through the duration of the project. • Trains, mentors, and oversees other Project Managers and conducts/participates in portfolio and project reviews.

Role Description Ulteig is seeking qualified candidates for the position of Associate Project Manager for the Power Lifeline Sector. In this role, you will manage small-to-medium size engineering and construction projects, ensuring they are delivered on time, within scope, and within budget. This position is intended to be based in Amarillo, TX. While remote candidates may be considered, Amarillo-based applicants are strongly preferred. What You’ll Do - Project Management - Lead small-to-medium Transmission and Substation projects from initiation through close-out for the Power Lifeline Sector. - Manage all aspects of project execution, including scope, stakeholder management, schedule, budget, and quality. - Lead internal and external project meetings, including progress reviews and problem-solving sessions. - Develop and implement project plans, including risk management and mitigation strategies. - Ensure that all project deliverables meet quality standards and client expectations. - Ensure availability or seeks out adequate resources to support the project. - Competent in analyzing problems, identifying alternative solutions, project consequences of proposed actions and implement recommendations to support project scope, schedule and cost objectives. - Collaboration & Communication - Function as the key project representative for clients, providing regular updates on project status and addressing any concerns. - Establish and maintain effective working relationships with those contacted in the course of work. - Work collaboratively with the Project Management Team to ensure project schedules and costs are managed and tracked to plan. - Maintain customer focus to meet or exceed customer expectations and represent Ulteig and Client in a professional and courteous manner. - Schedule & Cost Planning - Ensure that project timelines are maintained and milestones are met. - Monitor project progress and take corrective actions to keep projects on schedule, along with keeping the project plan up-to-date. - Monitor and control project budgets to prevent overspending. - Keep track of all financial transactions related to the project. - Monitor and control project costs. - Project Reporting & Compliance - Monitor ongoing project health and track key metrics. - Adhere to Client governance policies and procedures for project success. - Team Effectiveness - Demonstrates excellent leadership, verbal/written communications, time management, interpersonal, and organizational skills. - Achieves results by problem solving, setting priorities, and organization. - Collaborate with engineering teams to ensure that technical aspects of the project are properly managed. - Ensure that best practices are shared and implemented effectively across projects and teams. - Strive for individual excellence by seeking challenges and self-development, demonstrating high levels of expertise, and showing commitment, self-confidence, and integrity. Qualifications - Bachelor’s degree in Engineering, Project Management, Construction Management, Business Administration or equivalent experience. - 3+ years of experience in project administration/management or a related role in an engineering or construction environment, power industry experience preferred. - Basic Technical knowledge, with the ability to understand and coordinate solutions for complex challenges preferred. - Proficient understanding of project management and project controls. - Proficiency in Microsoft Office applications and project management software (e.g., MS Project, Primavera). - Travel to clients’ facilities for field visits and client meetings monthly (25%). - PE, PMP, CCM or equivalent certification a plus. - Must have authorization to work permanently in the U.S. Benefits - Flexible Workplace. - Employee Ownership. - Competitive Pay. - Comprehensive Benefits Package. - Collaborative Environment. - Innovative Culture.

• Build strong professional relationships with current and prospective clients • Identify new business opportunities from existing clients and communicate them to the Sales team • Develop and execute solutions for current and prospective clients • Support the Sales team to help close new business opportunities • Maintain close contact with the client whenever an issue is at stake to ensure proper resolution • Provide management with feedback and recommendations on necessary changes to streamline and/or improve the company's processes, procedures, and services • Provide supervision and mentoring and/or manage Project Managers and Project Specialists • Work with the Sales team and Project Managers to develop a schedule for projects and assure adequate communication lines are used during projects • Maintain and update key LanguageLine business systems, such as XTRF, LLTS Wiki, and other DBs to note all relevant client communication • Represent LanguageLine at trade shows, expositions, and conferences when necessary • Conduct visits to current and (possibly) prospective clients • Contribute to the Process and Quality Improvement Initiative by participating on cross-functional teams • Arrange and assign linguists for projects • Manage the relationships with linguists to encourage cooperation • Manage contractors to ensure their delivery of product on time • Monitor quality control procedures to ensure that all quality checks are completed • Consistently track projects; report status and key issues to Account Executives • Ensure that projects are delivered on time, on budget, and with the required level of quality • Authorize and sign-off on projects being delivered to clients • Ensure that projects are delivered to the clients' specifications and expectations, and in a manner befitting a world-class organization • Provide training and consulting services to Project Managers and participate as a consultant for systems development activities • Other duties as may be assigned