[Remote] Senior Regulatory Affairs Manager - Labeling (FSP) at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life Sciences, Clinical ResearchIndustries

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 coordinating readability testing, translations, and linguistic reviews for foundational markets (EU, CH, DE)
Knowledge of labeling systems (e.g., Documentum, Weblabel, Trackwise, Veeva)
Understanding of regulatory standards for foundational markets (US, EU, CH, DE, AU) and non-US/Central EU markets
Experience with Company Core Data Sheet (CCDS), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and related documentation
Familiarity with Health Authority (HA) interactions, submissions, and compliance (e.g., FDA-508, NDC assignments)

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
Oversee end-to-end labeling development and implementation for foundational (US, EU, CH, DE, AU) 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
Provide strategic input to therapeutic area teams

Skills

Regulatory Affairs

Global Labeling

Labeling Compliance

CTA Submissions

Promotional Materials Review

Regulatory Strategy

Document Management

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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