[Remote] Sr/ Regulatory Affairs Manager at Thermo Fisher Scientific

Mexico

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment
Expertise in international regulatory standards for labeling compliance
Ability to act as a labeling strategist, aligning company position, labeling requirements, and commercial opportunities
Knowledge of foundational markets (US, EU, CH, DE, AU) and non-US/Central EU markets regulatory processes
Familiarity with labeling systems (e.g., Documentum, Weblabel, Trackwise, Veeva)
Understanding of Company Core Data Sheet (CCDS), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC)
Experience with Health Authority (HA) interactions, submissions, and negotiations
Knowledge of FDA-508 compliance, quality control, and annual reporting (e.g., US drug listing, NDC assignments)
Awareness of EU Clinical Trial Regulation (CTR) and clinical trial authorization processes
Ability to manage SOPs, change controls, deviation reports, and electronic review systems

Responsibilities

Coordinate readability testing, translations, and linguistic reviews for foundational markets (EU, CH, DE)
Manage 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 CommitteeCompliance

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What are the key skills required for this position?

The role requires strong organizational, technical, and regulatory expertise, along with experience managing complex global labeling operations in a matrixed environment.

What does the team structure look like for this role?

The role is part of the Global Labeling & Lifecycle Document Specialist (GL&LDS) Team within Global Regulatory Affairs (GRA), involving collaboration in a matrixed environment and leadership of the Global Labeling Committee (GLC).

Is there any information on salary or compensation?

This information is not specified in the job description.

What makes a strong candidate for this Sr. Regulatory Affairs Manager role?

A strong candidate will have expertise in global regulatory compliance, labeling coordination across multiple markets, and experience in cross-functional collaboration within a matrixed environment.

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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