• Oversee projects ensuring adherence to applicable laws, regulations, and internal policies while driving successful project outcomes. • Spearhead the creation and implementation of compliance programs, transforming compliance requirements into actionable project plans. • Monitor project progress and compliance metrics, set ambitious yet achievable deadlines, and ensure high standards. • Act as the key liaison between compliance teams, project stakeholders, and department heads, fostering clear communication. • Conduct risk assessments to identify compliance gaps and project risks, and implement corrective actions. • Complete projects that meet compliance standards and set new benchmarks for quality and efficiency, ensuring certifications like ISO27001 are achieved.

• 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.