• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions • Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries • Oversee preparation and submission of regulatory documents • Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals • Provide strategic input to leadership on regulatory risk and risk mitigations • Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders • Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness • Represent regulatory interests in product development governance committees and decision-making processes

• Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content. • Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development. • Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification. • Training and oversight of additional FSP resources for artwork management • Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities. • Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs. • Support the development and maintenance of country regional text lists (cRTL). • Review of package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries. • Participate in cross-functional meetings to support product launches, labeling updates, and change control processes. • Support continuous improvement initiatives related to artwork review processes and labeling systems.

Role Description We are seeking a Contracts & Compliance Intern to support our Global Account Management Team with the opportunity to get hands-on experience in contract operations. - Responsible for various projects and initiatives to enhance the contract renewal process for existing Taulia clients, including high-profile clients. - Collaborate with various departments to ensure compliance and organization with legal and regulatory requirements. Qualifications - Current university student or recent graduate of a BS/MS/Ph.D university program in Law, Business, Public Administration, Management & Leadership, or related fields. - Familiarity with legal language and contracts. - Proficiency in Google Workspace, particularly Google Sheets and Google Drive. - An open mind with creative ideas for future initiatives to improve contracting process and record keeping. - Strong analytical, communication, and writing skills. - Inquisitive mind with a focus on continuous improvement. Requirements - Project management skills (nice to have). - Basic understanding of regulatory compliance (nice to have). Benefits - Flexible work schedule. - Remote-friendly environment. - Comprehensive Insurance Coverage (Medical, Dental, Vision, Life). - Comprehensive PTO Structure (PTO, Sick Leave, Bereavement). - Global Parental Leave. - Company issued equipment (Laptop, monitor, etc.). - 401k with match. - Career Development/Pathing. - EAP Program/Mental Health Advocacy. - Supportive Work Culture.

• Responsible for leading the organization’s audit and compliance programs, ensuring continuous alignment with regulatory, contractual, and security framework requirements. • Owns the end-to-end audit lifecycle, including planning, readiness, evidence management, auditor coordination, and remediation tracking across frameworks such as SOC 2, HITRUST, PCI DSS, HIPAA, and NIST CSF. • Act as the primary liaison between internal stakeholders and external auditors, ensuring audit readiness and sustained compliance posture. • Operates as a senior individual contributor responsible for driving compliance execution, maintaining control frameworks, and leveraging GRC tools to enable scalable and efficient compliance operations. • Leverage tools and technology to support Information Security audit, compliance, and GRC initiatives across the Information Security Program • Act as system administrator for certain security or GRC tools such as phishing and training platforms, GRC/IT Risk Management tools, Third Party Risk Management (TPRM) platforms, Risk Register, privacy management, etc. • Integrate related tools and workflows with other systems as needed. • Engage with internal stakeholders and security vendors on design sessions, and help configure and optimize GRC solutions and compliance workflows. • Work with IT partners in Application Security, Security Engineering and Operations, Enterprise Applications, Desktop Support, Help Desk, Networking and Infrastructure Operations, to get data and information needed to support GRC work and audit & compliance activities. • Collaborate with IT teams and Information Security teams to obtain security and operational data needed to support audit, compliance, and risk assessment activities. • Work with IT teams and partners to align GRC objectives with enterprise security controls and operational processes including cybersecurity / technology solutions such as IAM, PAM, MFA, RBAC, SSO, DLP, IDS/IPS, XDR, MDM, SIEM, etc. • Support data analysis, metrics, dashboards and reporting activities by pulling data from source systems. • Stay current with evolving regulatory requirements, compliance frameworks, industry trends, threat intelligence and make recommendations for process and control improvements. • Participate in security incidents and support related audit, compliance and remediation activities as needed. • Support security assessment requests for customers, HITRUST, SOC 2, etc. by pulling appropriate data as needed. • Work with IT partners to align GRC requirements with operational processes such as secure software development life cycle, software engineering, infrastructure, network, etc. • Maximize the utilization of GRC tools and technology to improve program efficiency and audit readiness • Assist with the development and maintenance of policies, procedures and compliance documentation. • Stay current with changes in information security and cybersecurity regulations, industry frameworks, and best practices, and apply them to existing NextGen GRC solutions and processes. • Use GRC and security engineering skills to help streamline or automate NextGen methodology for maintaining accreditations or certifications (e.g., SOC 2, HITRUST, etc.). • Use GRC and security engineering skills to help streamline or automate NextGen methodology for responding to customer security assessments or questionnaires.