Compliance

• Research and interpret environmental regulations and policies to support project compliance
• Help prepare and submit permit applications, compliance reports, and environmental documentation
• Support compliance with federal, state, and local environmental laws, including NEPA, CEQA, CWA, and CAA
• Conduct site visits and field assessments to monitor environmental conditions and regulatory adherence
• Collect and analyze air, water, and soil quality data and samples
• Assist with erosion control, stormwater management, and other environmental protection best management practices
• Conduct routine storm event and post-storm inspections for SWPPP, maps, and permit compliance
• Troubleshoot site compliance and BMP issues
• Prepare technical reports, impact assessments, compliance audits, monitoring logs, inspection logs, and field notes
• Support environmental impact mitigation planning and tracking
• Coordinate with regulatory agencies, project managers, construction personnel, client personnel, and field teams
• Participate in meetings and project discussions to provide regulatory insight
• Respond to compliance-related inquiries and project needs
• Stay current on environmental policies, industry trends, and best practices
• Participate in professional development and seek mentorship

Environmental Compliance Specialist I

• Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management of small molecule products
• Serve as CMC Regulatory lead on cross-functional program teams
• Provide strategic regulatory guidance throughout product development and commercialization
• Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management
• Assess regulatory risks, develop mitigation strategies, and provide regulatory recommendations
• Support products from IND through NDA approval and post-approval lifecycle management
• Lead preparation, review, and submission of global CMC filings, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports, and Health Authority responses
• Author and review Module 2 and Module 3 CMC documentation
• Coordinate cross-functional contributions and ensure regional regulatory compliance
• Represent CMC Regulatory Affairs in Health Authority meetings and responses
• Support inspection readiness and regulatory assessments related to manufacturing, quality systems, and product quality
• Develop filing strategies for post-approval CMC changes
• Guide formulation development, process development, scale-up, technology transfer, process validation, and commercial manufacturing
• Evaluate regulatory impacts of APIs, excipients, formulations, manufacturing processes, packaging systems, and manufacturing sites
• Provide oversight for analytical method development, validation, specifications, and stability programs
• Contribute to assessments of CMAs, CPPs, CQAs, control strategies, and pharmaceutical development
• Support combination product or biologic product regulatory activities when applicable

Associate Director, CMC Regulatory Affairs – Small Molecules

• Serve as the senior Compliance advisor to the Platforms vertical's commercial leadership and go-to-market teams
• Engage early in sales and business-development processes to identify compliance considerations and structure viable solutions
• Partner with Sales, Business Development, Partnerships, Account Management, Product, Legal, Financial Crime Compliance, and country Compliance teams
• Bridge commercial teams and country compliance teams by connecting commercial priorities with local regulatory requirements, risk appetite, and compliance guidance
• Advise on strategic opportunities involving platforms, marketplaces, enterprise clients, bank partners, and other complex commercial relationships
• Own Compliance outcomes for relationships with bank partners, card networks, stablecoin networks, and other payment infrastructure partners
• Evaluate compliance implications of two-tier business models involving platforms and underlying merchants, sellers, or customers
• Support compliant solutions for new platform models, customer segments, use cases, products, and payment flows
• Provide guidance on AML/CTF, sanctions, KYC/KYB, customer and partner due diligence, acceptable-use requirements, licensing considerations, and payment regulations
• Participate in customer and partner discussions when senior Compliance involvement is needed
• Assess higher-risk or nonstandard opportunities and recommend controls, conditions, or risk-mitigation measures
• Coordinate resolution of compliance questions and escalations affecting negotiations, onboarding, implementation, or launch
• Translate regulatory requirements into actionable guidance for commercial and business stakeholders
• Develop scalable commercial compliance frameworks, playbooks, and decision-making standards for the Platforms vertical
• Identify recurring commercial-process barriers and improve policies, controls, and workflows
• Deliver targeted training to customer-facing teams
• Provide senior leadership visibility into material commercial compliance risks, emerging trends, significant decisions, and unresolved issues
• Represent the Platforms vertical within Nium's global Compliance organization and commercial advisory framework

Head of Compliance – Platforms

• Own the global regulatory strategy for the botulinum toxin and biologics portfolio across the U.S., Korea, Europe, Canada, Australia, and Asia-Pacific
• Lead face-to-face negotiations and briefings with global health authorities, including FDA, Korean MFDS, EU authorities, Health Canada, and TGA
• Present regulatory strategy, risks, and recommendations to senior leadership and governance boards
• Partner with R&D and Clinical teams in Korea and the U.S. from early development through global submissions
• Guide CMC, manufacturing, and comparability strategy for post-approval changes and lifecycle initiatives
• Serve as the senior regulatory voice on business development and due diligence for biologic assets and transactions
• Drive lifecycle management and geographic expansion for marketed products, including new indications and markets
• Collaborate with R&D, Clinical, CMC, Manufacturing, Quality, Medical, Commercial, and regional regulatory teams

Senior Director, Global Regulatory Lead – Biologics

• Own product strategy and execution for privacy, data governance, and responsible data use across Plaid’s platform
• Ensure products and internal systems handle consumer data compliantly, transparently, securely, and consistently with Plaid’s values and commitments
• Serve as the connective PM between Legal, Security, Data, Engineering, and Product teams
• Operationalize privacy requirements into scalable product solutions
• Define and drive the roadmap for privacy-related platform capabilities, including consent, data minimization, retention, deletion, and access controls
• Translate evolving regulatory requirements into product requirements and system designs
• Partner with Legal, Policy, and GTM to identify privacy risks and opportunities
• Work with Engineering to design privacy-by-default and privacy-by-design architectures
• Balance privacy protections with usability and performance for customers and developers

Product Manager, Privacy & Data Governance

• Ensure the accuracy of import/export data and customs records
• Ensure an optimal flow of merchandise in compliance with applicable laws and regulations
• Serve as internal import/export expert
• Perform daily compliance screenings against OFAC sanctions
• Identify, reconcile, and resolve issues promptly
• Review shipments and advise relevant partners on USMCA status of goods
• Maintain trade compliance records according to internal policies and applicable laws and regulations
• Assign and audit material classifications, including Harmonized Tariff Schedule and Schedule B
• Follow up and resolve messages for filings with CBP
• Identify issues and continuous improvement opportunities
• Collaborate with appropriate departments to resolve issues and address opportunities
• Partner with the Senior Manager Compliance to ensure procedures and SOPs are current and accurate
• Assist with preparation and filing of annual reports, reconciliation reports, and certification letters
• Participate in continuing education related to international trade and governmental regulations
• Report to the Manager - Trade Compliance

Trade Compliance Specialist

• Lead or support integrated global CMC regulatory strategies for T-cell drug product and lentiviral vector programs
• Serve as Regulatory CMC representative on program and technical teams
• Convert program decisions into regulatory requirements, submission plans, health authority engagement strategies, risks, mitigations, and decision points
• Define phase-appropriate CMC content and evidence expectations
• Provide regulatory guidance for autologous T-cell manufacturing processes and assess manufacturing process changes
• Guide T-cell control strategy, including quality attributes, process parameters, in-process controls, specifications, potency, identity, purity, viability, safety testing, and comparability criteria
• Support site additions, technology transfers, manufacturing network expansion, process performance qualification, comparability, validation, and post-approval change strategies
• Provide regulatory guidance for lentiviral vector manufacture and assess LVV process and analytical changes
• Guide LVV control strategy and develop regulatory approaches for LVV comparability and bridging
• Define phase-appropriate IND/CTA CMC packages and prepare or review submissions, amendments, health authority questions, and regulatory meeting materials
• Drive CMC readiness for pivotal studies and BLA/MAA submissions
• Lead or support responses to information requests, deficiency letters, and health authority meeting questions
• Assess post-approval changes and change controls
• Support inspection readiness by aligning filings with site practices, validation status, manufacturing history, quality systems, and commitments
• Author, coordinate, and critically review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and post-approval commitments
• Maintain registered details, regulatory commitments, correspondence, assumptions, and decision history
• Present status, risks, options, and recommendations to technical teams and leadership
• Contribute to Regulatory CMC templates, playbooks, precedents, intelligence, and training
• Coach less experienced colleagues and fulfill people-leader accountabilities

Senior Manager, Regulatory Affairs CMC

• Lead or support integrated global CMC regulatory strategies for T-cell drug product and lentiviral vector programs
• Serve as Regulatory CMC representative on program and technical teams
• Translate program decisions into regulatory requirements, submission plans, health authority strategies, risks, mitigations, and decision points
• Provide regulatory guidance for autologous T-cell manufacturing across production, testing, storage, shipping, and chain-of-identity/chain-of-custody controls
• Assess T-cell and LVV process, analytical, equipment, supplier, site, scale, formulation, and manufacturing changes
• Guide T-cell and LVV control strategies, comparability, bridging, validation, stability, potency, safety, and reference standards
• Define phase-appropriate IND/CTA CMC packages and support early-stage development
• Prepare and review CMC content for submissions, amendments, scientific advice, and regulatory meetings
• Drive CMC readiness for pivotal studies, BLA/MAA submissions, commercial readiness, and post-approval lifecycle activities
• Author, coordinate, and review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and commitments
• Support inspection readiness, site additions, technology transfers, manufacturing network expansion, and post-approval changes
• Present status, risks, options, and recommendations to technical teams and leadership
• Contribute to Regulatory CMC templates, playbooks, precedents, intelligence, and training
• Coach less experienced colleagues and lead selected Regulatory CMC sub-teams or special initiatives
• Create inclusion, develop talent, and empower teams as a people leader

• Coordinate activities related to client security audits, vendor security audits, ISO 27001 assessments, penetration test remediations, and other client responses
• Lead assigned client security reviews from intake through closure
• Identify necessary internal stakeholders for security surveys, audits, and reviews
• Assemble relevant documentation and complete required forms and questionnaires
• Maintain relationships with third-party audit services and independent consultants
• Act as project manager for ISO 27001, client, and vendor audits and other assessments
• Establish schedules, coordinate stakeholders, meet deadlines, track follow-up, and complete necessary responses
• Support penetration and vulnerability testing compliance activities
• Identify critical systems and external testing requirements and frequency
• Coordinate with Security Operations and follow up on remediation activities to ensure processes and SLAs are met
• Coordinate team activities and review work for consistency and quality
• Create reports and presentations for senior management

Enterprise Security Compliance Lead

• Drive day-to-day federal compliance execution, security assurance, and audit readiness for SMCI Federal
• Complete and maintain NIST SP 800-171 self-assessment scoring and SPRS submissions
• Own, manage, and update the System Security Plan (SSP) and Plan of Action & Milestones (POA&M)
• Track and close control gaps against defined SLAs
• Maintain incident response readiness for DFARS 72-hour reporting requirements
• Lead annual incident response tabletop exercises and ensure rapid, accurate security-event reporting
• Validate technical safeguarding controls delivered through GCC High and SMCI-operated systems against NIST SP 800-171
• Establish and administer Technology Control Plans and technical access controls for controlled technical data
• Operate deemed-export prevention processes across engineering, sales, and manufacturing
• Support and validate physical protection controls at the dedicated federal facility, including badge access, visitor management, and physical safeguarding of CUI
• Partner with Facilities and Security on control design for spaces where CUI or ITAR-controlled technical data is handled
• Deliver an assessment-ready posture for third-party CMMC Level 2 certification audits
• Independently validate technical security controls and maintain separation of duties
• Drive and track completion of mandatory CUI, ITAR, and insider-threat training
• Support insider-threat access-lifecycle controls and reporting channels with HR and Security
• Maintain the compliance evidence repository and CUI-environment asset inventory
• Support evaluation of GRC tooling as the program matures

Compliance jobs in California

Environmental Compliance Specialist I

Associate Director, CMC Regulatory Affairs – Small Molecules

Head of Compliance – Platforms

Senior Director, Global Regulatory Lead – Biologics

Product Manager, Privacy & Data Governance

Trade Compliance Specialist

Senior Manager, Regulatory Affairs CMC

Senior Manager, Regulatory Affairs CMC

Enterprise Security Compliance Lead

Security Compliance Specialist