Role Description Ein Innovatives, klinisch ausgerichtetes Biotech-Unternehmen mit Fokus auf neuartige Therapien in der Onkologie ist auf der Suche nach Verstärkung. Die starke Pipeline und moderne Technologien prägen das Wachstum. Sie arbeiten an komplexen Entwicklungsprogrammen und gestalten aktiv den Weg zur Zulassung. Geboten wird echter Einfluss auf regulatorische Strategien für innovative Therapien. Regulatory CMC Associate Director (m/w/d) Standort: 100% Remote (auf Mitarbeiterwunsch auch Office-based in Süddeutschland möglich) - Steuerung der EU CMC Strategie für mehrere klinische Programme - Übersetzung technischer Änderungen in regulatorisch belastbare Strategien - Entwicklung von Lösungen für Comparability, Spezifikationen und Prozessänderungen - Frühzeitige Identifikation regulatorischer Risiken und Ableitung pragmatischer Maßnahmen - Führung von CMC-Aktivitäten für klinische Prüfungsanträge und Änderungen - Erstellung strukturierter, hochwertiger Einreichungsdokumentation - Gestaltung von Strategien für Behördenkommunikation - Vorbereitung und Begleitung von Interaktionen mit EU-Behörden - Sicherstellung regulatorischer Compliance externer Herstellungspartner - Enge Zusammenarbeit mit Quality und technischen Fachbereichen - Aktive Verfolgung regulatorischer Entwicklungen im CMC-Umfeld - Beitrag zur Weiterentwicklung regulatorischer Standards im Unternehmen Qualifications - Studium in Naturwissenschaften, Pharmazie oder vergleichbarer Fachrichtung - Mind. 6 Jahre Erfahrung in Regulatory Affairs CMC für Biologics oder ATMPs - Fundierte Kenntnisse der EU-Regularien und GMP-Anforderungen - Erfahrung mit klinischen Prüfungsanträgen und Behördeninteraktionen (inkl. Scientific Advice) - Selbstständige Arbeitsweise in komplexen, dynamischen Umfeldern - Strukturierte, pragmatische und lösungsorientierte Denkweise - Hohe Eigenverantwortung und ausgeprägte Teamfähigkeit - Sehr gute Englischkenntnisse, Deutsch von Vorteil Benefits - Strategische Position in einem internationalen Umfeld - Flexibles Arbeitsmodell mit viel Gestaltungsspielraum - Innovatives Arbeiten mit moderner Pipeline - Attraktive Vergütung und Zusatzleistungen Company Description Als erfahrene Marktspezialisten vermitteln wir Traumjobs in den Bereichen Pharma & Medical Device – zielgerichtet, effektiv und nachhaltig.

Build a Safer World. TRM Labs provides blockchain analytics and AI solutions to help law enforcement and national security agencies, financial institutions, and cryptocurrency businesses detect, investigate, and disrupt crypto-related fraud and financial crime. TRM’s blockchain intelligence and AI platforms include solutions to trace the source and destination of funds, identify illicit activity, build cases, and construct an operating picture of threats. TRM is trusted by leading agencies and businesses worldwide who rely on TRM to enable a safer, more secure world for all. You’ll play a pivotal role in helping our customers meet their regulatory and financial crime compliance obligations. This includes deep engagement with financial institutions, crypto native businesses, regulators, and cross-functional internal teams to ensure our tools, strategies, and guidance reflect the highest standards of compliance—across areas like anti-money laundering (AML), sanctions, KYC, and broader financial crime risk. With accelerating demand from financial institutions entering the market, increasing regulatory engagement globally, and growing momentum with financial institutions, we’re at an inflection point. We’re seeking an additional Compliance Advisor to help us keep pace with our opportunity set and meet the rising complexity and scale of our work. This role will report into the Head of Compliance Advisory and partner cross-functionally with go-to-market, product, policy, and customer success teams. The impact you’ll have here: - Support customers in navigating complex compliance-related inquiries and building compliance controls, particularly as our footprint expands in key markets - Build credibility and trust with compliance leaders at global financial institutions, accelerating adoption across APAC and North America - Anticipate and adapt to evolving financial crime and regulatory landscapes—ensuring our customers receive accurate, actionable insight on everything from AML controls to emerging laundering typologies - Deliver clear, consistent guidance that empowers both our internal teams and external stakeholders to uphold robust financial crime compliance standards - Represent our platform in high-stakes conversations with regulators, banking partners, and policy influencers—bringing a strong, informed perspective on financial crime risk and compliance integrity What we’re looking for: - 4+ years of experience in AML compliance roles within large financial institutions - Thorough understanding of the different functions within a financial crime compliance program inclusive of risk assessments, KYC, transaction monitoring, and sanctions, including workflows, challenges, effectiveness strategies, and key regulatory issues - Experience advising stakeholders on how to interpret and meet their regulatory obligations - Global regulatory fluency, with working knowledge of key frameworks in the APAC, US, and/or EMEA - Experience supporting and/or leading engagements with financial institutions, regulators, or government bodies - A practical and scalable approach to compliance—you’re thoughtful about risk, but not dogmatic - Excellent communication skills and sound judgment; able to operate autonomously with influence and credibility across senior external stakeholders - A low-ego, highly collaborative teammate who thrives in cross-functional environments - Fluency in another language is a plus - Willingness to travel to speak at conferences in multiple regions About the Team: Our Compliance Advisory team is a globally distributed group of experts with backgrounds in financial institutions, regulatory bodies, and high-growth technology companies. We operate at the intersection of compliance, product, and customer engagement—helping some of the most innovative businesses in the world meet their regulatory obligations without slowing down. Each team member brings deep financial crime expertise and a strong sense of ownership to a highly collaborative, fast-moving environment. We maintain alignment through weekly global syncs, cross-functional risk reviews, and focused huddles when high-stakes issues arise. In between, we rely heavily on written communication—Slack, Notion, and Loom—to ensure we’re moving quickly and staying on the same page. Our team culture is anchored in clarity, responsiveness, and shared accountability. We value curiosity, strong judgment, and a bias toward practical solutions. As a globally distributed team, members may observe different timezones, however, this role will be mostly APAC coverage with occasional overlap for other timezones. Learn about TRM Speed in this position: We identify emerging regulatory changes in a key market and deliver internal guidance within 48 hours. - For example, when a new AML directive is released, we quickly analyze its relevance, brief GTM and product stakeholders, and share a synthesized summary with action recommendations—all before competitors begin reacting - We don't wait for someone to ask; we anticipate, package, and deliver with velocity and clarity We support a financial institution’s onboarding by building a tailored control framework proposal in 5 days. - Rather than getting bogged down in red tape, we pull from prior engagements, adapt our templates, and proactively flag potential concerns to speed up adoption and reduce friction in compliance reviews - We meet institutional expectations without slowing down commercial momentum We jump into regulatory conversations on short notice, even without perfect prep. - When a regulator requests a briefing on how our platform supports sanctions screening, we coordinate internally and deliver a thoughtful, compliance-forward perspective the same week - We value precision—but in a high-growth environment, velocity matters. We iterate and improve fast, rather than delay Life at TRM We are building a safer world. That promise shows up in how we work every day. TRM moves quickly. We are a high velocity, high ownership team that expects clarity, follow-through, and impact. People who thrive here are energized by hard problems, experimentation, and continuous feedback. If something takes months elsewhere, it will ship here in days. Our work sits at the intersection of AI, national security, and fighting financial crime. The problems are complex, the stakes are real, and the environment evolves quickly. The pace and intensity of the work reflect the importance of the mission. As a result, the way we operate requires a high level of ownership, adaptability, collaboration, and creative problem-solving. At TRM, you should expect: - Priorities and targets to change quickly as we experiment and iterate - Work that often requires operating with a high degree of ambiguity - A high level of personal ownership and accountability - Close collaboration across teams and functions - Frequent, high-touch communication - Creative problem solving and out-of-the-box thinking - A pace that rewards urgency, adaptability, and outcomes This environment is energizing for people who enjoy building, solving hard problems, and making progress in situations that are not always fully defined. It also requires comfort navigating ambiguity, adjusting course as new information emerges, and maintaining focus and positivity in a fast-moving and intense environment. We also recognize that this style of operating is not for everyone. If you are primarily optimizing for predictability or a consistently balanced workload, we encourage you to use the interview process to pressure test whether this environment is truly the right fit. We want teammates who thrive here, not just survive here. At the same time, many people find this work deeply rewarding. If you are excited by meaningful problems, motivated by ambitious goals, and energized by working alongside mission-driven colleagues, there is a good chance you will find TRM to be an exceptional place to grow and contribute. Learn more: Interviewing at TRM: How We Hire and What Success Looks Like AI Fluency at TRM AI fluency is a baseline expectation at TRM. We believe AI meaningfully changes how top performers operate. We expect every team member to use AI to accelerate and reimagine their craft, not just automate surface tasks. At TRM, AI fluency means you are among the top 10 percent of operators in your function in how you apply AI to: - Accelerate repeatable workflows - Structure and solve problems - Improve output quality - Increase speed and leverage You will be evaluated on applied AI fluency during the interview process. Leadership Principles We hire and grow against three leadership principles. They’re the standards for how we operate, treat each other, and make decisions. - Impact-Oriented Trailblazer: We put customers first and move with speed, focus, and adaptability. We treat every plan like an experiment – test, ship, measure, and iterate quickly. - Master Craftsperson: We care deeply about our craft. We balance speed with high standards, own outcomes end‑to‑end, and invest in getting better everyday. - Inspiring Colleague: We add clarity and energy, not noise. We bring humility, candor, and a one‑team mindset — giving and receiving feedback to make the team stronger. Join our Mission At TRM we care deeply about our craft. We are looking for individuals who want their work to matter, who experiment with speed and rigor, and who take pride in building a safer world for billions of people. If you’re excited by TRM’s mission but don’t check every box, we encourage you to apply — we hire for slope, judgment, and the will to learn fast. TRM is a Series C company with $220M in total funding, backed by Blockchain Capital, Goldman Sachs, Bessemer, Y Combinator, Thoma Bravo, and others. Headquartered in San Francisco, TRM operates as a distributed-first company with hubs in Los Angeles, San Francisco, New York, Washington D.C., London, and Singapore. Privacy Policy and Additional Information By submitting your application, you are agreeing to allow TRM to process your personal information in accordance with the TRM Privacy Policy. Our typical hiring cycles for specialized roles span 24 to 36 months. Accordingly, we retain your personal information for up to 36 months to evaluate your application and to consider you for current and future employment opportunities, unless you request earlier deletion or a different retention period is required or permitted by law. To notify TRM Labs that you believe this job posting is non-compliant, please submit a report through this form. No response will be provided to inquiries unrelated to job posting compliance. The use of AI tools of any kind (including but not limited to notetakers, interview assistants, and real-time coaching tools such as Otter.ai, Fireflies, Fathom, Cluey, or similar) during TRM interviews is not permitted without prior approval from TRM. TRM uses its own internal tools for note-taking to ensure a consistent and confidential experience for all candidates. We are committed to providing reasonable accommodations to applicants with disabilities, and requests can be made via this form. Recruitment agencies TRM Labs does not accept unsolicited agency resumes. Please do not forward resumes to TRM employees. TRM Labs is not responsible for any fees related to unsolicited resumes and will not pay fees to any third-party agency or company without a signed agreement. Learn More: Company Values | Interviewing | FAQs

• Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO’s positions in assigned states. • Develop comprehensive strategic plans to facilitate effective engagement with legislative and regulatory stakeholders to achieve GEICO’s business objectives. • Regulatory & Legislative Analysis: Review and evaluate impactful insurance regulatory/ legislative proposals, working in close collaboration with relevant Government & Regulatory Affairs colleagues and other internal stakeholders. • Ensure that GEICO's business units and corporate functions remain informed about critical and emerging issues. • Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making. • Strategic Support: Work with the Director of Public Policy and business stakeholders to develop policy positions, strategy, responses/draft language; prepare for legislative and regulatory interactions; and support company’s strategic initiatives. • Coalition Building: Support the strategic implementation of GEICO’s key public priorities through coalition building and coordination of external resources. • Maximize outside firms and association memberships to successfully advocate GEICO’s priorities. • Develop and execute effective and efficient political contributions strategies in assigned states, in consultation with business, to enhance GEICO’s policy agenda. • Assume other regulatory or legislative responsibilities as priorities evolve.

Job Description General Summary: The Regulatory Labeling Senior Manager, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes. Key Duties and Responsibilities: - Provides individual contribution in development, submission, negotiation and approval of ROW labelling. - Ensures compliance with labelling governance requirements and associated business processes. - Participates in label working groups and representing labelling at labelling governance meetings. - Works with Labelling Operations to ensure alignment with Package Component Labelling - Provides input into strategy for health authority interactions and advises stakeholders of regulatory labelling requirements regarding all aspects of labelling, including responses to questions, negotiations and inspections. Knowledge and Skills: - In-depth conceptual and practical knowledge regarding labelling requirements globally, use of CCDS or reference label (US and EU) in the development and management of local labelling. - Ability to develop, use, and apply knowledge of frameworks specific to regulatory regional labelling, and to use this information to support regulatory responsibilities that align with business objectives. - Ability to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory global and/or regional labelling in a systematic and efficient manner. Education and Experience: - Bachelor’s degree - Extensive years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience Pay Range: $141,600 - $212,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com