[Remote] Associate Director, Regulatory Affairs (Labeling) - FSP at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment
Ability to act as a labeling strategist within Global Regulatory Affairs (GRA), ensuring alignment of company position, labeling requirements, and commercial opportunities
Expertise in foundational markets (US, EU, CH, DE, AU) and non-US/Central EU markets regulatory standards
Knowledge of international regulatory standards for labeling, submissions, and compliance (e.g., FDA-508, EU Clinical Trial Regulation (CTR))
Experience with labeling systems (e.g., Documentum, Weblabel, Trackwise, Veeva) and internal/external platforms

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, 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
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
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
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
Maintain multi-market manuscripts and master artwork files
Coordinate administrative labeling updates (e.g., address or Windsor updates) for EU and other markets
Oversee end-to-end labeling development and implementation for foundational and non-US/Central EU markets
Oversee regulatory review and approval of promotional and non-promotional materials to ensure global compliance
Manage global Clinical Trial Authorization (CTA) submissions and strategy, aligning labeling and regulatory documentation for clinical programs

Skills

Key technologies and capabilities for this role

Regulatory AffairsGlobal LabelingCCDSUSPISmPCDocumentumWeblabelTrackwiseVeevaCTA SubmissionsReadability TestingTranslationsLinguistic ReviewsGlobal Labeling CommitteePromotional Materials Review

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This is an office-based role with standard Monday-Friday hours and office environmental conditions.

What are the key responsibilities of this role?

The role involves coordinating global labeling activities, managing preparation and submission of labeling documents, overseeing regulatory review of materials, and ensuring compliance across foundational and dependent markets.

What skills and expertise are required for this position?

The position requires strong organizational, technical, and regulatory expertise, experience in a matrixed environment, and knowledge of international regulatory standards for labeling.

What is the work environment like for this role?

The role operates within a matrixed environment in Global Regulatory Affairs, involving coordination with foundational and dependent markets, and collaboration with cross-functional teams like Medical Affairs, Legal, and Commercial.

What makes a strong candidate for this Associate Director role?

Strong candidates will have expertise as a labeling strategist, experience overseeing end-to-end global labeling for key markets like US and EU, and skills in managing regulatory submissions, compliance, and cross-functional collaboration.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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