• The Regulatory Expert – Ecotoxicology acquires knowledge of recent regulatory scientific advances in the area of Ecotoxicology and is able to translate these into ways to organize and prepare registration dossiers for conventional and biological plant protection products. • The Regulatory Expert – Ecotoxicology oversees and is accountable for lower and higher-tier assessments requiring involvement of more junior Regulatory Ecotoxicologists. • Primary responsibility stands with ecotoxicology dossier section writing for both active substances and formulated products dossiers • Performs, the assessment of client ecotoxicological data (data gap analysis and preliminary risk assessments) for the active substance and/or product dossiers under the focus of appropriate and specific regulatory requirements. • Supports the Section Leader the Regulatory Ecotoxicologists for preparation of comprehensive technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy and clarity of presentation of results. • Supports the Section Leader in the preparation of strategies to assist clients in dossier preparation including experimental programs according to European and national data requirements. • In collaboration with the Section Leader, and Regulatory Ecotoxicologists organises experimental work compromising requesting, quoting, monitoring and time scheduling in and outside the Eurofins Agroscience Services Group. • Monitors standard lower and higher-tier as well as non-standard studies. • In the frame of Study Monitoring, engages closely with Study Directors and keeps a close contact with the laboratories and all other relevant Regulatory groups (e.g. phys-chem & Analytical Methods). • Supports clients in the frame of their dossier stewardship post-submission / dossier defence. • In collaboration with the Section Leader and Principal Scientist compiles and maintains regulatory documentation and tools. • In collaboration with the Section Leader organizes all project-related activities related to the area of Ecotoxicology under the most recent regulatory legislation requirements and scientific guidelines. • Follows-up closely on latest developments in the regulatory fields related to ecotoxicology that are influencing the quality of the deliverables. • In collaboration with the Section Leader identifies, analyses and proposes ways of implementation of relevant guidance documents in the preparation of regulatory documentation. • Attends and actively participates in internal and external Ecotoxicology Conferences, seminars but also clients’ meetings whenever required. • Supports on Producing Regulatory Science documentation (articles, posters, webinars, etc.) in the area of Ecotoxicology supporting marketing/sales activities.

Role Description The Case Manager is responsible for the day-to-day management and operations of expanded access clinical trials, ISTs and EA (“Compassionate Use”) cases including the management of vendors, clinical monitors and participating IST and EA sites. This position will also work closely with cross-functional teams to ensure that these programs are conducted in a timely fashion and in a manner compliant with ICH/Good Clinical Practice (GCP)/regulatory guidelines and SOPs as well as company goals and budgets. Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities - Manages the operational aspects of expanded access clinical trials, Investigator Sponsored Trials (ISTs), Early Access (“Compassionate Use”) cases and Sponsored Research. - Participates in protocol, informed consent, CRF development, Clinical Study Report preparation, NDA submission, as appropriate. - Prepares metrics and updates for management, as assigned. - Manages case/study timelines and budgets. - Proactively identifies potential issues/risks and recommends/implements solutions. - Participates in and facilitates CRO/vendor selection process for outsourced activities. - Manages CRO/vendor interactions, providing sponsor oversight of operational activities (e.g., case management, monitoring, project master files), develops and revises scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met. - Prepares and/or reviews/approves case-related documents/templates, as appropriate (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines), and site-related documents (informed consent template and tools/worksheets), investigator contracts, and site payments. - Manages case monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regional/country specific regulations. - Recommends and implements innovative process ideas to impact early access clinical trials management. - Organizes and manages internal cross-functional review meetings, team meetings, investigator meetings and other case-specific meetings, as required. - Serves as an internal liaison and resource for Investigators/Physicians and Medical Science Liaisons (MSLs). - Participates in the selection, training and evaluation of department personnel (contract and internal) to ensure the efficient operation of the function, and may manage and mentor Ultra Programs staff. - Participates in the development, review and implementation of departmental SOPs, processes, templates and tools. Qualifications - Bachelor’s degree or relevant experience required. - Experience in rare diseases is a plus, but not required. - Willingness to address urgent treatment requests when needed. - 5+ years of relevant industry experience, with at least 3 years of direct clinical trial management experience at a Sponsor/Company or CRO. - Proven ability to provide functional expertise to a clinical development program in a specified product area with experience in managing CROs, specialty labs, outside vendors and international trials. - Late Phase or Phase IV experience a plus, but not required. - Familiar with advanced concepts of clinical research with demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA and Country regulations/ICH guidelines, is required. - Must possess a high degree of customer focus towards internal and external stakeholders; strong collaboration skills, excellent planning skills and able to manage multiple projects with time demands. - Problem solver and effectively works in a team environment. - Highly effective verbal and written communication skills required. - Minimal travel may be required. Benefits - Generous vacation time and public holidays observed by the company. - Volunteer days. - Long term incentive and Employee stock purchase plans or equivalent offerings. - Employee wellbeing benefits. - Fitness reimbursement. - Tuition sponsoring. - Professional development plans. - Benefits vary by region and country.

Senior Associate, Regulatory Affairs (US) locations Remote (US) time type Full time job requisition id R34514 BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements. The role assumes end‑to‑end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands‑on mindset, as well as the ability to operate as a flexible, collaborative team player who is open to learning and adapting in a fast‑paced, deadline‑driven environment. This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements; it is not an entry‑level position. Essential Functions of the Job: - Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance. - Draft regulatory submission documents (e.g., IND components) as required. - Review regulatory documentation to ensure accuracy, consistency, and completeness, and supports the effective execution of regulatory submissions to health authorities. - Serve as the primary execution lead and cross‑functional coordinator for assigned U.S. regulatory submissions, ensuring clarity of roles, timelines, and deliverables. - Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies. - Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and to collect and organize FDA submission-ready documents. - Perform Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements. - Liaise with Regulatory Publishing to support on‑time, first‑cycle‑quality FDA submissions. - Maintain IND, NDA, and BLA submission archives ensuring version control, document integrity, and inspection readiness. - Request FDA application numbers via the CDER NextGen Portal and support FDA correspondence tracking. - Utilize regulatory tracking tools (e.g., Veeva Vault RIM, submission trackers) to monitor milestones, deliverables, and risks. - Monitor FDA guidance updates and contribute to continuous improvement of US submission processes. Supervisory Responsibilities: - None Computer Skills: - Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools. - Proficiency in Microsoft Office (Word, Excel, PowerPoint) - Ability to manage submission timelines, trackers, and Master Document Lists. - Proficiency in Microsoft Office. Other Qualifications: - BA/BS degree, preferably in a scientific or health‑related discipline OR 3+ years of Regulatory Affairs experience, including hands‑on support of U.S. IND preparation required. - Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. - Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable. - Assist regulatory affairs team/strategist in supporting strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. - Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad. - Demonstrates sound judgment and practical business awareness in supporting regulatory activities and execution decisions. - Demonstrates ability to function as a trusted cross‑functional partner in a matrixed regulatory environment. - The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment. - Hands‑on, execution‑driven mindset with accountability for deliverables and outcomes. - Clear written and verbal communication with cross-functional teams. - Ability to work independently and collaboratively under tight FDA-driven timelines. - Strong organizational and documentation skills - Ability to manage multiple US submissions and priorities simultaneously Travel: N/A Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. - Fosters Teamwork - Provides and Solicits Honest and Actionable Feedback - Self-Awareness - Acts Inclusively - Demonstrates Initiative - Entrepreneurial Mindset - Continuous Learning - Embraces Change - Results-Oriented - Analytical Thinking/Data Analysis - Financial Excellence - Communicates with Clarity Salary Range: $40.91 - $52.91 per hour BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Role Description We are looking for a Regulatory Reporting Senior Specialist to join our expanding team. In this role, you will be a key operational driver of our reporting function, ensuring the flawless execution of our regular reporting frameworks, supporting complex regulatory cycles, and collaborating closely with our data analysts and IT teams during a period of high-impact product innovation. If you have a solid foundational knowledge of banking regulations, 3–5 years of hands-on experience, and an interest in growing within a fast-paced fintech environment, we encourage you to apply. - Execute End-to-End Delivery: Ensure the flawless compilation, meticulous proofing, and timely submission of regulatory reports, ensuring total adherence to monthly, quarterly, bi-annual, and annual cycles. - Support Core & Liquidity Frameworks: Take hands-on ownership of regular COREP, FINREP, statistical, and national reporting workflows, with a strong operational focus on liquidity reporting, capital requirements (Basel Pillar 1 and 3), and essential groundwork. - Support Audits & Remediations: Assist in preparing documentation and act as a reliable point of contact for internal and external auditors during regular audit cycles. - Project Support: Act as an operational contributor for new company initiatives and innovations, helping to review and integrate regulatory requirements before go-live. - Maintain Data & Systems Infrastructure: Collaborate closely with the Data and IT teams to refine data pipelines, handle data requests, update interface descriptions, and support automation processes within our core reporting engine (BAIS). - Cross-Functional Alignment: Represent the Regulatory Reporting function in daily alignments with key stakeholders across Risk, Controlling & Credit, Treasury, Accounting, and authorities. Qualifications - At least 3 to 5 years of solid, hands-on operational experience within regulatory reporting at a licensed bank, financial institution, or financial outsourcing company. - A degree in Business Administration, Finance, Business Engineering, or a traditional banking education with appropriate further qualifications. - Practical, working knowledge of European financial and banking legislation (including CRR, CRD, KWG, and AnaCredit). - Proven experience working directly with regulatory reporting software - ideally BAIS (or equivalent industry-standard software like Abacus/Regnology) - alongside advanced Excel skills and comfort working with data/IT interfaces. - Practical experience participating in external audit cycles and preparing reporting documentation for authorities. - A strong interest in the intersection of financial regulation and IT, with a proven ability to map out interface descriptions and support complex data migration or transition projects. - Strong analytical capacity, a highly structured approach to problem-solving, and excellent communication skills. Fluent in both German and English is mandatory. Benefits - Accelerate your career growth by joining one of Europe’s most talked about disruptors 🚀. - Employee benefits that range from a competitive personal development budget, work from home budget, discounts to fitness & wellness memberships, language apps and public transportation. - As an N26 employee you will have access to a Premium subscription on your personal N26 bank account, as well as subscriptions for friends and family members. - Additional day of annual leave for each year of service. - A high degree of autonomy and access to cutting edge technologies - all while working with a friendly team of peers of diverse nationalities, life experiences and family statuses. - A relocation package with visa support for those who need it.