Work Schedule Standard Mon-Fri Environmental Conditions Office At Thermo Fisher Scientific Inc you ll discover meaningful work that makes a positive impact on a global scale Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research our work spans laboratory digital and decentralized clinical trial services Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future Summarized Purpose The Global Labeling Lifecycle Document Specialist GL LDS Team is responsible for managing global labeling activities and ensuring compliance with international regulatory standards This role coordinates all aspects of labeling processes across foundational and dependent markets including the preparation submission and maintenance of labeling documents The position requires robust organizational technical and regulatory expertise to manage complex global labeling operations within a matrixed environment Acts as a labeling strategist within Global Regulatory Affairs GRA ensuring alignment of company position labeling requirements and commercial opportunities Oversees end-to-end labeling development and implementation for foundational US EU CH DE AU and non-US Central EU markets Oversees regulatory review and approval of promotional and non-promotional materials to ensure global compliance Manages global Clinical Trial Authorization CTA submissions and strategy aligning labeling and regulatory documentation for clinical programs Responsibilities Labeling Coordination Management Coordinate readability testing translations and linguistic reviews for foundational markets EU CH DE Manage the preparation review and upload of approved labels to internal systems Documentum Weblabel intranet and external platforms HA ePIL Dispatch CCDS foundational labels and multi-market manuscripts to dependent markets stakeholders and partners Oversee and perform data entry for labeling systems Trackwise Veeva and maintain labeling records Maintain and update Company Core Data Sheet CCDS US Prescribing Information USPI and EU Summary of Product Characteristics SmPC Lead Global Labeling Committee GLC assessments and manage exceptions between CCDS and regional labels Governance Compliance Support label content creation including development of DLS and CCDS documentation Prepare materials for Labeling Review Committee LRC and Global Labeling Committee GLC ensuring accurate record-keeping of decisions and minutes Manage global labeling compliance activities including quality control FDA-508 compliance and annual reporting requirements US drug listing and NDC assignments Coordinate impact assessments for technical and global labeling changes Ensure compliance with country-specific regulatory requirements for labeling submissions and artwork approvals Regulatory Cross-Functional Support Prepare change control documentation and deviation reports for foundational and non-foundational markets Manage Health Authority HA requests RFIs and label negotiations Provide regulatory support for advertising promotion and medical education materials to ensure compliance with approved labeling and regional requirements Collaborate with Medical Affairs Legal and Commercial teams to review and approve promotional and non-promotional materials Manage Standard Operating Procedures SOPs and electronic review systems related to labeling and promotional review Provide strategic input to therapeutic area teams and influence external labeling landscapes through competitive intelligence and regulatory insight Act as key partner to GRA Regions Regulatory CMC and Supply Chain to ensure accurate and timely implementation of labeling decisions Clinical Trial Regulatory Responsibilities Develop and oversee global Clinical Trial Authorization CTA submission strategy Act as the regulatory interface between labeling clinical operations and global health authorities Ensure compliance with EU Clinical Trial Regulation CTR and other regional regulatory requirements Operational Administrative Activities Maintain multi-market manuscripts and master artwork files Coordinate administrative labeling updates e g address or Windsor updates for EU and other markets Prepare annual strain update labeling Northern and Southern Hemispheres Participate in GRAST meetings and GL Leadership bi-weekly updates Qualifications Minimum of 5 years of experience in the biotech or pharmaceutical industry including 2 years in labeling Demonstrated experience leading teams and initiatives in a matrixed organizational structure In-depth knowledge of global labeling lifecycle management and regulatory requirements for US EU DE CH and AU markets Proven ability to manage multiple complex projects under tight deadlines Experience reviewing technical and scientific documents and influencing cross-functional teams Familiarity with labeling for flu campaigns pandemic products and promotional material compliance Experience with CTA submissions and coordination of global regulatory documentation preferred Education and Experience Education Bachelor s degree 4-year degree in Life Sciences Chemistry Engineering or a related Pharmaceutical field Preferred Advanced degree MSc PhD or PharmD Experience Minimum of 5 years in the biotech pharmaceutical industry with at least 2 years in regulatory labeling Technical Skills Proficient with regulatory and document management systems including RIMS Veeva RIMS eDMS Veeva Apollo Docubridge Change Management Trackwise Other Tools Microsoft Office Suite SharePoint Adobe Acrobat TVT Promomats GLAMS Knowledge of Structured Product Labeling SPL preparation and submission Understanding of FDA-508 compliance and digital labeling requirements Experience with electronic promotional review and approval systems e g Promomats and CTA submission platforms Competencies Demonstrated ability to act as a labeling strategist and thought leader within Global Regulatory Affairs Strong understanding of regulatory requirements relevant to global drug development labeling and post-marketing obligations Excellent analytical and problem-solving skills with the ability to assess risks and recommend effective solutions Cross-functional collaboration and communication skills with proven success working in culturally diverse global teams Exceptional organizational skills to manage multiple priorities and ensure compliance with regulatory standards Strategic and detail-oriented thinking with the ability to influence and communicate complex concepts clearly Fluent in English verbal and written additional languages are an asset