Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients. You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings. The following skills are required to be successful in this position: - preparation and assembly of global regulatory submissions - interacting with sponsors, - review and assess clinical trial regulatory documents, - review and assess scientific literature. - manages project teams and preparation - participate in launch meetings, review meetings and project team meetings. Optional skills: - Experience with bid defense meetings Qualifications - External What the role requires you to have: - Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job - Knowledge of the global clinical trials landscape Knowledge, Skills and Abilities: - Excellent command of the English language (written and oral) as well as local language where applicable - Excellent attention to detail and quality as well as excellent editorial/proofreading skills - Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments - Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies - Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects - Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables - Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines - Excellent analytical, investigative and problem-solving skills

At monday.com, we help teams get more work done. We are the best AI work platform that empowers teams to automate, build, and scale their impact end-to-end with tools that actually execute the work for you. With over $1B in ARR, 250,000+ customers, and a global team, we’re serious about building a product people love to use and giving our employees the same ownership and flexibility to shape the way the world works. If you are an execution master that thrives in a dynamic multitasking environment, loves to make things happen, excel in leading projects to successful execution and relentlessly seeks to define and refine operational processes, this role is a huge opportunity for you! monday.com is looking for an experienced Engineering Operations & Programs Manager to join our team. In this role you will be a key driving force in the execution of Engineering & Product initiatives and plans to meet our targets, while taking a significant part in running the operational side of the teams. You will be leading cross-functional projects from idea to full execution. You will establish and maintain project scope, objectives, plans and milestones to achieve project goals, improve and maintain work processes related to the building of our product and enabling our fast rapid scale. #LI-DNI - 7+ years of experience from a technological company in project management and/or operational role with a deep understanding and know-how in developing processes. - Engineering or Product experience is a big plus - Can-do approach with a strong sense of ownership. - Independent, self-starter, learn and move fast. - Organized, details oriented with the ability to handle multiple projects & activities simultaneously while meeting targets. - A “people person” with excellent communication skills, should be able to communicate with a wide range of stakeholders to create strong collaboration. - Team player, egoless with a proactive approach that thrives in a dynamic, ever-changing environment. - Excellent writing and verbal communication skills in English.

Job descriptions may display in multiple languages based on your language selection. What we offer: At Magna, you can expect an engaging and dynamic environment where you can help to develop industry-leading automotive technologies. We invest in our employees, providing them with the support and resources they need to succeed. As a member of our global team, you can expect exciting, varied responsibilities as well as a wide range of development prospects. Because we believe that your career path should be as unique as you are. Group Summary: Transforming mobility. Making automotive technology that is smarter, cleaner, safer and lighter. That's what we're passionate about at Magna Electronics, and we do it by creating world-class Electronic systems. We are a premier supplier for the global automotive industry with full capabilities in design, development, testing and manufacturing of complex Electronic systems. Our name stands for quality, environmental consciousness, and safety. Innovation is what drives us and we drive innovation. Dream big and create the future of mobility at Magna Electronics. Job Responsibilities: Position in Magna Electronics Japan Duties and responsibilities The Manager - Program Management is responsible for all program management activities related to one or several customers in Japan, covering the entire product life cycle (from pre-acquisition through end of production), as well as acquisition support for new programs & program-related communications. The position includes team management to achieve business objectives on a larger scale. Manage programs - In charge of all program's activities - Secure program activities are performed at a global scale to achieve objectives - Assess the risks encountered for each program in his scope and define mitigation actions - Support serial life maintenance activities - Ensure process compliance - Ensure all applicable processes & standards are followed - Support gate preparation/reporting activities and deviations process when needed - Conduct regular program status reviews and assist in decision making. - Communicate/negotiate with customers/suppliers in alignment with Sales and Purchasing Manage financials - Manage overall customer(s) programs budget - Monitoring using standard tools & processes - Plan vs Actual reconciliation - Early risk escalation - Manage overall customer(s) programs KPIs - Meet or overachieve target KPIs for customer programs ncl.VA/VE - Identify financial risks & manage recovery plans Manage customer(s) - Build customer(s) trust - Establish relationships with key customer contacts for the decision making process - Understands customer's business and speaks their language - Develops credibility, loyalty, trust and commitment - Manage customer program health - Maintain deep customer knowledge (process, organization - Establish monthly management review - Provides to all related entities customer feedback on products and features Support business development - Support quotation & risk assessment phases for new business acquisition - Support the preparation and business case review of quotations for customers - Involve in quotes targeting profitable and/or strategic business opportunities - Support post-competition phases - Support contract reviews when awarded, and lessons learned for lost business Manage a team - Direct management a group of Program Managers to achieve business objectives - Identify opportunities for development and define development plan / career path - Ensure compliance to company policies and procedures together with well-being at work Must Have Requirements - Working Experience: 9+ years of project/program management experience - Strong technical background in product development - Diploma: Bachelor's Degree Required or equivalent - Must possess ability to lead/direct assignments and development of program managers Soft skills - Keen listening, open-mindedness, and strong interpersonal skills - Find creative solutions and generate results in a dynamic market environment - Able to focus on delivering services in a way that enhances / maximizes profitability Nice to Have Skills and Experience - ADAS systems or Electronics experience - SW development experience or knowledge Other - Team player - Self-motivated - Clear and concise in communication - Independent thinker - Ability to take initiative and overcome obstacles - Self-learner Languages - English: communication in English with members in other regions such as US and India - Japanese: Fluent reading & writing including with Japanese customers Awareness, Unity, Empowerment: At Magna, we believe that a diverse workforce is critical to our success. That's why we are proud to be an equal opportunity employer. We hire on the basis of experience and qualifications, and in consideration of job requirements, regardless of, in particular, color, ancestry, religion, gender, origin, sexual orientation, age, citizenship, marital status, disability or gender identity. Magna takes the privacy of your personal information seriously. We discourage you from sending applications via email or traditional mail to comply with GDPR requirements and your local Data Privacy Law. Worker Type: Regular / Permanent Group: Magna Electronics

• Support the definition, refinement, and tracking of Fan 1:1 domestic and international program objectives, milestones, and success metrics. • Ensure alignment of program goals with strategic frameworks and organizational priorities. • Maintain and improve tracking mechanisms to monitor timelines, risks, dependencies, and deliverables. • Evaluate existing 1:1 workstreams and help identify gaps, opportunities, and new areas of focus. • Assist in the setup and documentation of new workstreams, including ownership, scopes, and reporting cadences. • Coordinate across D&A, Marketing, MarTech, Legal, and other cross functional teams to ensure seamless delivery. • Prepare concise program updates, dashboards, and readouts for leadership and stakeholders. • Consolidate inputs across workstreams into clear narratives, risks, recommendations, and progress summaries. • Support planning and working sessions to ensure program goals remain relevant and aligned. • Build strong working relationships across teams and serve as a connector between business and technical partners. • Help translate business needs into actionable requirements for analytics, engineering, and other technical groups. • Coordinate analytics fulfillment and reporting requests to support data-driven decision-making.