Director Regulatory Affairs (Labeling)- FSP at Thermo Fisher Scientific

Reinach, Basel-Landschaft, Switzerland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

12+ years of experience, including 5+ years in a management role
Proven leadership in a matrixed organizational structure
In-depth knowledge of global labeling lifecycle management
Demonstrated ability to manage complex projects under tight deadlines
Experience with CTA submissions and global regulatory documentation
Bachelor’s degree or equivalent experience in Life Sciences, Chemistry, Engineering, or related field; Advanced degree preferred
Proficient with regulatory and document management systems such as Veeva RIMS, Trackwise, and others
Knowledge of Structured Product Labeling preparation and submission
Understanding of FDA-508 compliance and digital labeling requirements
Strong strategic and analytical skills
Effective cross-functional collaboration and communication abilities
Outstanding organizational skills and attention to detail
Proficient in English; additional languages are an asset

Responsibilities

Coordinate readability testing, translations, and linguistic reviews for foundational markets
Manage the preparation, review, and upload of approved labels to internal and external platforms
Dispatch CCDS and multi-market manuscripts to dependent markets and collaborators
Coordinate data entry for labeling systems and maintain accurate labeling records
Maintain and update critical labeling documents such as CCDS, USPI, and SmPC
Lead Global Labeling Committee assessments and manage regional label exceptions
Support the creation of label content, including DLS or equivalent experience and CCDS documentation
Prepare materials for Labeling Review Committee and ensure accurate record-keeping
Manage global labeling compliance activities, including quality control and annual reporting
Coordinate impact assessments for technical and global labeling changes
Ensure adherence to country-specific regulatory requirements for labeling and submissions
Prepare change control documentation and manage Health Authority requests
Provide regulatory support for advertising and promotional materials to ensure compliance
Collaborate with Medical Affairs, Legal, and Commercial teams for material reviews
Manage SOPs and electronic review systems related to labeling
Provide strategic input to therapeutic area teams and influence external labeling landscapes
Develop and coordinate global Clinical Trial Authorization submission strategies
Act as the regulatory interface between labeling, clinical operations, and health authorities
Ensure adherence to regional regulatory requirements
Maintain multi-market manuscripts and master artwork files
Coordinate administrative labeling updates for various markets
Prepare annual strain update labeling for both hemispheres
Participate in GRAST meetings and bi-weekly GL Leadership updates

Skills

Regulatory Affairs

Labeling Compliance

CCDS

USPI

SmPC

Readability Testing

Translations

Linguistic Reviews

Global Labeling

SOP Management

Change Control

Quality Control

Health Authority Submissions

Label Review Committee

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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