Senior Regulatory Affairs Manager (Labeling) FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific Inc. youll 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 strong organizational technical and regulatory expertise to manage complex global labeling operations within a matrixed environment.

Responsibilities

• 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 collaborators and partners.
• Coordinate 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) evaluations and handle exceptions between CCDS and regional labels.

Governance & Compliance

• Support label content creation including development of DLS or equivalent experience and CCDS documentation.
• Assemble materials for the Labeling Review Committee (LRC) and Global Labeling Committee (GLC) maintaining accurate records 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).
• Manage impact evaluations for technical and global labeling modifications.
• Ensure adherence to 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 assistance for advertising promotion and medical education materials to ensure alignment 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 coordinate global Clinical Trial Authorization (CTA) submission strategy.
• Act as the regulatory interface between labeling clinical operations and global health authorities.
• Ensure adherence to 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

• A minimum of 8 years working in the biotech or pharmaceutical sector including over 2 years dedicated to labeling
• Demonstrated experience leading teams and initiatives in a matrixed organizational structure.
• Comprehensive understanding of global labeling lifecycle management and regulatory requirements for US EU DE CH and AU markets.
• Demonstrated capability to handle several intricate projects within strict time constraints.
• 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: Bachelors degree or equivalent experience (4-year degree) in Life Sciences Chemistry Engineering or a related Pharmaceutical field.
• Preferred: Advanced degree (MSc PhD or equivalent experience or PharmD).
• Experience: A minimum of 8 years working in the biotech/pharmaceutical sector with no less than 2 years dedicated to regulatory labeling.

Technical Skills

• Proficient with regulatory and document management systems including:

RIMS: Veeva RIMS

1. eDMS: Veeva Apollo Docubridge

Change Management: Trackwise

1. Other Tools: Microsoft Office Suite SharePoint Adobe Acrobat TVT Promomats GLAMS

• Knowledge of Structured Product Labeling (SPL) preparation and submission or equivalent experience.
• Understanding of FDA-508 compliance and digital labeling requirements.
• Experience with electronic promotional review and approval systems (e.g. Promomats) and CTA submission platforms.

Proficiencies

• Demonstrated ability to act as a labeling strategist and an inspiring leader within Global Regulatory Affairs.
• Strong understanding of regulatory requirements relevant to global drug development labeling and post-marketing obligations.
• Strong analytical and problem-solving abilities with the capacity to evaluate risks and suggest effective solutions.
• Cross-functional collaboration and communication skills with proven success working in culturally diverse global teams.
• Outstanding organizational abilities to prioritize several tasks and guarantee adherence to regulatory standards.
• Strategic and diligent thinking with the ability to influence and communicate complex concepts clearly.
• Proficient in English (verbal and written); additional languages are an asset.