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

Germany

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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

Minimum of 10 years working in the biotech or pharmaceutical sector, including more than 2 years dedicated to labeling
Demonstrated experience leading teams and initiatives in a matrixed organizational structure
Comprehensive understanding of worldwide labeling lifecycle management and regulatory demands for US, EU, DE, CH, and AU markets
Established skill in handling numerous challenging projects under pressing deadlines
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: Bachelor’s 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: At least 10 years in the biotech or pharmaceutical field, including a minimum of 2 years in regulatory labeling and over 5 years managing teams; Demonstrated leadership abilities
Proficiency in technical skills (as described)

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 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)
Support label content creation, including development of DLS or equivalent experience and CCDS documentation
Prepare materials for Labeling Review Committee (LRC) and Global Labeling Committee (GLC), ensuring records of decisions and minutes are accurate
Manage global labeling compliance activities, including quality control, FDA-508 compliance, and annual reporting requirements (US drug listing and NDC assignments)
Manage impact analyses for technical and global labeling changes
Ensure adherence to 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 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

Skills

Regulatory Affairs

Global Labeling

CCDS

USPI

SmPC

Documentum

Weblabel

Trackwise

Veeva

Readability Testing

Translations

Linguistic Reviews

FDA-508 Compliance

Label Review Committee

Global Labeling Committee

Change Control

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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