Regulatory Affairs Cmc Associate Jobs

Sr. Director of Commercial and Legal Affairs About Backblaze Backblaze is a public company that makes storing and using data astonishingly easy. When our founding team got together, they committed to helping people save their data. Today, the Backblaze Storage Cloud provides a foundational platform around the world for a broad community of developers, IT generalists, entrepreneurs, and individuals who seek the easy, affordable, trusted solutions we provide. We have managed to nurture a team-oriented culture with amazingly low turnover. Our approach is guided by honesty, transparency, and a commitment to doing the right thing. Our customers are happy, and so are our coworkers: in the most recent “Great Place to Work” survey, 97% of our team rated Backblaze as “a great place to work.” Check out what our employees are saying on Glassdoor! About the Role We are seeking a Sr. Director of Commercial and Legal Affairs to lead and oversee Backblaze’s commercial, privacy, and product legal functions. This is a people leader role that will serve as a strategic business partner across Sales, Product, Engineering, Security, and Compliance. The ideal candidate is a highly experienced commercial lawyer with a strong track record of drafting and negotiating complex technology transactions, including enterprise and strategic partnership deals. This role also requires fluency in privacy and data protection issues and hands-on experience advising product and engineering teams throughout the product lifecycle. This position will play a critical role in enabling scalable growth while thoughtfully managing legal and regulatory risk as Backblaze continues to expand globally. This role includes people management responsibilities and will lead, mentor, and develop attorney(s) and legal professional(s) supporting commercial, privacy, and product work. This role reports to the Head of Legal & Compliance and is fully remote (US-based). What You’ll Do Commercial Leadership and Deal Executi

Sr. Director of Commercial and Legal Affairs About Backblaze Backblaze is a public company that makes storing and using data astonishingly easy. When our founding team got together, they committed to helping people save their data. Today, the Backblaze Storage Cloud provides a foundational platform around the world for a broad community of developers, IT generalists, entrepreneurs, and individuals who seek the easy, affordable, trusted solutions we provide. We have managed to nurture a team-oriented culture with amazingly low turnover. Our approach is guided by honesty, transparency, and a commitment to doing the right thing. Our customers are happy, and so are our coworkers: in the most recent “Great Place to Work” survey, 97% of our team rated Backblaze as “a great place to work.” Check out what our employees are saying on Glassdoor! About the Role We are seeking a Sr. Director of Commercial and Legal Affairs to lead and oversee Backblaze’s commercial, privacy, and product legal functions. This is a people leader role that will serve as a strategic business partner across Sales, Product, Engineering, Security, and Compliance. The ideal candidate is a highly experienced commercial lawyer with a strong track record of drafting and negotiating complex technology transactions, including enterprise and strategic partnership deals. This role also requires fluency in privacy and data protection issues and hands-on experience advising product and engineering teams throughout the product lifecycle. This position will play a critical role in enabling scalable growth while thoughtfully managing legal and regulatory risk as Backblaze continues to expand globally. This role includes people management responsibilities and will lead, mentor, and develop attorney(s) and legal professional(s) supporting commercial, privacy, and product work. This role reports to the Head of Legal & Compliance and is fully remote (US-based). What You’ll Do Commercial Leadership and Deal Executi

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description As the primary Public Affairs liaison to the R&D organization, the V ice P resident will develop and execute an integrated internal and external communications strategy that advances enterprise priorities, strengthens trust in our science, and enables business readiness for key pipeline and regulatory events. This leader will provide senior counsel to R&D and enterprise leaders on reputation and risk, set the operating model and governance for R&D communications globally, and build a high-performing team with deep scientific, regulatory, and issues-management expert

As the Associate/Laboratory Director, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and rare disease testing on platforms including SNP array analysis, NGS, and other methodologies. Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: appropriate test method selection; adequate method verification to determine the accuracy and precision of the test; enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed; PT samples are tested in accordance with the CLIA requirements; PT results are returned within the time frames established by the PT program; PT reports are reviewed by the appropriate staff; corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory; quality assessment and quality control programs are established and maintained; acceptable analytical test performance is established and maintained for each test system; remedial actions are taken and documented when signific

As the Associate/Laboratory Director, Oncology and one of our Laboratory Directors, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including the Signatera MRD assay and other Next Generation Sequencing based assays. Oversee the review of genetic and CNV variant data: interpret NGS results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: appropriate test method selection; adequate method verification to determine the accuracy and precision of the test; enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed; PT samples are tested in accordance with the CLIA requirements; PT results are returned within the time frames established by the PT program; PT reports are reviewed by the appropriate staff; corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory; quality assessment and quality control programs are established and maintained; acceptable analytical test performance is established and maintained for each test system; remedial actions are taken and documented when significant deviations from the laboratory’s established

Location : Barcelona At Freenow by Lyft, our purpose is to serve and connect. We aim to achieve this by cultivating a work environment where all team members belong and have the opportunity to thrive. Our Global Sustainability team drives the company’s sustainability strategy, decarbonization, risk management, and reporting commitments across the markets we operate in. As Freenow by Lyft continues to expand its European operations, the regulatory landscape (e.g., CSRD, CSDDD, EU Taxonomy, and electric vehicle mandates) is becoming more complex. This team partners closely with Legal, Finance, Operations, and Global Growth to ensure Lyft not only meets its compliance obligations but builds sustainability practices that scale with the business. We’re searching for a strategic, detail-oriented operator to join as Sustainability Manager for Freenow by Lyft, based in Barcelona. This person will report to Lyft’s Global Sustainability Manager, own strategy implementation and reporting of Lyft’s sustainability initiatives across our European markets, with a particular focus on navigating the EU’s regulatory environment. This is a foundational role for the region: you’ll build the infrastructure, data management processes, and stakeholder relationships needed to ensure we are ahead of evolving disclosure requirements while advancing the company’s broader sustainability goals. YOUR DAILY ADVENTURES WILL INCLUDE: Regulatory Strategy & Compliance Own Europe’s sustainability implementation and roadmap, ensuring alignment with global sustainability goals and evolving EU regulatory requirements (CSRD, TCFD, and related frameworks). Monitor the EU regulatory landscape for emerging sustainability requirements and translate them into actionable business recommendations. Partner with Legal to interpret new and upcoming regulations and assess their operational impact. Carbon Accounting & Data Management Lead carbon accounting efforts across Europe, including da

Associate/Laboratory Director of Oncology, Comprehensive Genomic Profiling Position Summary As an Associate Lab Director or Lab Director of Oncology, you have clinical oversight of Natera’s laboratory testing related to cancer testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. You are responsible for ensuring the test validation and development meets all required regulatory standards. This position will be primarily responsible for technical and clinical performance of Natera’s comprehensive genomic profiling (CGP) assays. Title and scope of responsibility will be commensurate with the candidate’s experience. This position is on-site at Natera’s San Carlos, CA Laboratory. Primary Responsibilities Provide clinical sign-out and interpretation for CGP reports, identifying actionable biomarkers and relevant clinical trials Provide technical and clinical support for laboratory staff, genetic counselors, and other clinical personnel Ensure acceptable levels of analytical performance for CGP assays, compliance with applicable standards, and laboratory inspection-readiness at all times Troubleshoot workflow and laboratory issues with clinical care and regulatory standards in mind Document findings and maintain accurate records consistent with Natera policies and procedures May serve as Clinical Consultant . A Clinical Consultant is responsible for ensuring: Test reports include pertinent information for test interpretation, and Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions Qualifications Education: MD/DO and/or PhD in genetics or related field required. Board Certification: ABMGG board-certified in Clinical Cytogenet

POSITION SUMMARY As the Laboratory Director and one of our Laboratory Directors, you have clinical oversight of Natera’s laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results. PRIMARY RESPONSIBILITIES: Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and oncology testing on platforms including SNP array analysis, NGS, and other methodologies. Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data. Provide clinical and technical support for genetic counselors and other laboratory personnel. Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained. Analyze lab data, contribute to or write publications for high-quality scientific journals. May serve as Clinical Consultant. The Clinical Consultant is responsible for ensuring: Test reports include pertinent information for test interpretation, and Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: Appropriate test method selection Adequate method verification to determine the accuracy and precision of the test Enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed PT samples are tested in accordance with the CLIA requirements PT results are returned within the time frames established by the PT program P

Spotify's Legal team is growing. We're facing innovative challenges that mirror the groundbreaking industry and product at the heart of our company. As we've expanded into more than 180 markets and our business has grown tremendously, we find ourselves facing new and interesting legal issues every day — including an increasing volume of patent disputes alongside the copyright and content matters that have always been central to our work. As Legal Counsel, Litigation, you will work on a variety of litigation, copyright, patent, and other contentious and advisory matters, and help craft the way our company thinks about and handles them. The work we face is constantly developing, and the workload is growing faster than we can, so we will look to you to think thoughtfully about processes and policies that will help meet our goals. Your experience making risk-based assessments and proactively finding solutions to complex problems will be crucial. Significant e-discovery experience and experience conducting confidential inquiries are a plus. What You'll Do Coordinate litigation, pre-litigation, regulatory, and other dispute matters across multiple practice areas, including copyright and patent litigation. Work with outside counsel to develop case strategy, manage budgets, and drive efficient resolution of contentious disputes. Partner with the business on litigation and legal risk issues and work with colleagues to fashion solutions that balance legal risk with company objectives. Develop litigation case strategies, work closely with Spotify's communications team, and formulate plans to resolve disputes efficiently. Plan strategically and coordinate internally with legal and non-legal personnel on issues of the moment. Provide proactive advice to internal team members on dispute avoidance and resolution, including risk mitigation. Identify and mitigate threats against the company, whether from partners, users, con

Start date: Immediate Salary: $140,000 - $150,000 (bonus eligible) Location: New York, N.Y. or Washington, D.C. (Hybrid) ABOUT BERLINROSEN BerlinRosen is part of Orchestra, a strategic communications and marketing company built for today’s complex and fragmented world. From decoding audiences to designing bold strategies, Orchestra integrates people, platforms, and stories that stick to help clients build lasting influence. The company offers programs that span from the highest level strategic business counsel through to tactical execution. Orchestra brings together 700+ people with experience across consumer and lifestyle, technology, nonprofit and philanthropy, real estate, sports, travel, hospitality, and more. Made up of leading firms BerlinRosen , Civitas Public Affairs Group , Derris , Glen Echo Group , Inkhouse , M18 , Message Lab , Onward and Small Girls PR . It also launched Brightmode , a talent acquisition firm for communications professionals, and Versus Media Group , a strategy-first political media team. Learn more at www.orchestraco.com . People of all backgrounds and abilities are strongly encouraged to apply. Orchestra is committed to building and maintaining a diverse staff, and recognizes that its continued success depends on hiring and retaining high-quality creative professionals with a variety of backgrounds and experiences. Opportunities for advancement exist, and we are committed to helping all staff develop and grow. ABOUT THE PUBLIC AFFAIRS TEAM Our Public Affairs team is a group of strategists, campaign managers and communications experts who help clients navigate high-stakes political, regulatory and reputational challenges. We lead integrated campaigns across media, stakeholder engagement, advocacy, research and paid media, coordinating seamlessly across internal teams and external partners to drive outcomes for clients across healthcare, nonprofits, technology, land use, education, infrastructure and other sectors. The team

About LeafLink LeafLink is the largest unified B2B cannabis platform, providing licensed cannabis businesses a suite of tools to manage their business more effectively, sell or order from their favorite brands and accelerate growth. We are one platform, one solution and we’re defining the way thousands of cannabis brands, distributors, and retailers streamline their operations. With thousands of brands and retailers across 30+ markets in North America, we are setting the industry standard for how cannabis businesses grow together. LeafLink processes more than $5 billion in wholesale cannabis orders annually. Our team, backed by funding from leading VC's, including Founders Fund, Thrive Capital, Nosara Capital, and Lerer Hippeau is poised to define the cannabis supply chain through technology. LeafLink was named one of Inc. 5000’s ‘Top 5000 Fastest-Growing Private Companies’; one of Fast Company's 'Top 10 Most Innovative Companies in Enterprise for 2020', joining the ranks of Amazon, Slack, and VMWare; one of Built In NYC's 'Best Places to Work in 2021'; 2024 Fast Company’s Best WorkPlaces for Innovators for Banking, Finance, and Fintech category; 2024 Green Market Report Award for Best Fintech in cannabis - and we're just getting started! The Role LeafLink seeks a highly skilled Senior BSA/AML Analyst with deep expertise in high-risk complexity banking environments. In this role, you will own end to end financial crimes investigations across a diverse cannabis client portfolio, serving as subject matter expert on FinCEN guidance, state-level MRB regulations, and the unique typologies that emerge when embedded banking infrastructure meets federally controlled industries. This is not a routine compliance role – it requires regulatory prowess, business judgement, and the ability to operate with ambiguity. What You’ll Be Doing Monitor and investigate AML alerts generated across multiple program partners. Conduct due diligence and ongoing monitoring of cannabis cli

Spotify is looking for a culturally fluent, strategically sharp, and creative Communications Lead to shape and share our story across MENAT+. You’ll lead communications across the Middle East, North Africa, Türkiye, and Pakistan, helping Spotify strengthen its reputation, champion regional creators, and show up in ways that feel relevant to the audiences and communities we serve. Reporting to the Head of Communications, SAMEA, you’ll work closely with regional leadership and Spotify’s global communications teams across consumer, corporate, policy, industry, executive, and internal communications. This is a senior individual contributor role for someone who combines strategic judgment with hands-on execution and knows how to navigate culturally dynamic, fast-moving markets. What You'll Do Shape and execute an integrated communications strategy for MENAT+, putting regional creators, audiences, and culture at the heart of Spotify’s storytelling. Be a trusted communications partner to regional leadership, providing clear counsel on business priorities, reputation, emerging issues, and high-impact moments. Anticipate reputational opportunities and risks and help Spotify respond thoughtfully and effectively as cultural, media, policy, and regulatory dynamics evolve. Lead creator-first and earned-first storytelling that builds fandom, discovery, and cultural relevance, finding compelling stories in emerging scenes, communities, and moments that matter locally. Partner with Music, Podcasts, Product, Growth, Marketing, Public Affairs, and other teams to develop communications that support Spotify’s regional priorities. Connect MENAT+ priorities and perspectives with Spotify’s global communications strategy, while translating global priorities in ways that resonate with local audiences. Lead corporate, executive, internal, and B2B communications, including executive positioning, thoug

About the Team OpenAI’s mission is to ensure that general-purpose artificial intelligence benefits all of humanity. We believe that achieving our goal requires effective engagement with public policy stakeholders and the broader community impacted by AI. Accordingly, our Global Affairs team builds authentic, collaborative relationships with public officials and the broader AI policymaking community to inform and support our shared work in these domains. We ensure that insights from policymakers inform our work and - in collaboration with our colleagues and external stakeholders - support the development of regulation, industry standards, and safe and beneficial development of AI tools. About the Role As the EU Policy & Partnerships Manager, you will develop strategies, shape OpenAI’s approach to priority EU policy issues, and drive campaigns as part of our European team. You will also develop and manage relationships with key stakeholders across the Brussels policy ecosystem, including policymakers, regulators, civil society groups, industry associations, researchers and experts, seeking to advance policies and partnerships that align with OpenAI’s mission. OpenAI releases industry-leading research and tools. You will face new challenges as the impact of cutting-edge generative AI technologies continues to be explored and as the needs of the organization evolve. Day-to-day work may encompass anything from helping to shape strategic initiatives and developing policy positions to preparing our leaders for engagements with EU officials or representing OpenAI in private and public forums. We are looking for a self-directed and creative individual with deep EU policy expertise, experience managing relationships across the Brussels policy ecosystem, sound judgment, and a sophisticated understanding of AI and AI-related legislative and regulatory issues and processes. The ideal candidate will be able to move between strategic policy development and practical delivery,

About HopSkipDrive At HopSkipDrive, our mission is to create opportunity for all through mobility. We're the leader in safe, fast, and simple supplemental student transportation. Through our marketplace, we connect kids to highly-vetted caregivers on wheels. Through our software, we solve the biggest transportation challenges facing schools and school districts across the country. Founded by three moms as a solution to their own transportation challenges, we've now facilitated more than five million rides across over over 20states. We continue to grow rapidly — earning a spot on the Inc. 5000 list numerous times and the Deloitte 500 Fast-Growing Technology list. HopSkipDrive is a Series D company and has raised $100M to date. How we work We use AI every day, and not as a productivity add-on. It's woven into how we work at every level. We're rethinking how work gets done, who does what, and what a small team can accomplish. If you've already built AI into how you work, you'll hit the ground running. If you haven't, you'll need to be ready to learn fast and work differently than you have before. Who We Are The Legal team works hand-in-hand with leaders across the company to support HopSkipDrive’s growth, innovation, and strategic initiatives. It's an integral and highly impactful team that provides legal advice and guidance to ensure the company operates within legal boundaries while protecting intellectual property, financial interests, and regulatory compliance. We navigate complex legal landscapes to mitigate risks and support innovation. This is an exciting opportunity to learn in a fast-paced environment and own high-priority projects. The team is embracing AI as a core part of how we work, and is investing in building AI agents and other legal tech tools to modernize contracting and other legal functions. What You’ll Do Revamping and revitalizing the contract review process for efficiency with a focus on AI use. Overseei

Job Title Senior Clinical Development Scientist, Ultrasound &EI Job Description In this role, you have the opportunity to Be a member of the medical and clinical affairs team in Greater China. Medical and Clinical affairs team is an integral part of global Chief Medical Office. The Clinical Development Scientist is responsible for executing evidence-generation processes, clinical development and market access strategies for New Product Introduction (NPI) projects and post-market activities. The role is responsible for analyzing clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributes to the study designs. The role drafts comprehensive Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and regulatory submissions, ensuring accuracy and compliance with regulatory requirements. The role maintains data integrity and accuracy throughout studies and performs rigorous literature searches and critical reviews to support evidence-generation processes, providing insights for strategic decision-making. You are responsible for Assesses clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributing to the development and refinement of study designs as needed, working under direct supervision. Executes clinical development and market access strategies for assigned New Product Introduction (NPI) projects and post-market activities, integrating inputs from stakeholders such as Marketing/BU Claims, regional/market needs, Health Economics, Market Access, and Post Market Surveillance (PMS). Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing meticulous attention to detail and adherence to regulatory standards.<