[Remote] Sr Manager, EU & APAC Regulatory Affairs at Thermo Fisher Scientific

Netherlands

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Contract Development and ManufacturingIndustries

Requirements

Advanced Degree or equivalent experience in European Life Science (e.g. Pharmacy, Chemistry, Microbiology)
Minimum 12 years of relevant pharmaceutical regulatory affairs experience in the drug substance large molecule space (including CMC technical dossiers writing)

Responsibilities

Matrix manage EU & APAC DSD large molecule network (5 sites, 5 people) within assigned business units (BIO, mRNA, VVS): partner with site line managers on regulatory talents strategies, staff recruitment, on-boarding, development, career journey/succession; collaborate on HR calendar turning points such as goals setting, calibration, and performance reviews
Monitor, anticipate, pre-evaluate, and communicate major pharmaceutical regulations impacting large molecule Drug Substance business; participate in reputable industry associations, influence trends, provide SME consultation; improve internal regulatory knowledge through forums and trainings
Collaborate in PSG Quality transformation via compliance and QMS inputs (Global Policy, Procedures, Job Aids, Position Papers) and implementation; support regulatory systems automation, digital transformation, simplification, and harmonization; oversee site regulatory compliance (domestic licenses, foreign accreditations, master documents like SMF/DMF), support major inspections' preparedness with Qualified/Responsible Persons; perform product regulatory compliance duties, leverage systems, resolve critical quality issues with Qualified Person/Site Quality Head
Enhance regulatory services offering and revenue generation: identify and develop growth areas with creative business models; influence key EU & APAC projects for new product introduction/technology transfers or strategic customers; lead major regulatory quotations; deliver expertise on registration files (IMPD-MAA/IND-NDA-BLA) and post-approval changes (variations/PAS-CBE30-AR), assess regulatory acceptance/risk
Define DSD large molecule yearly objectives, ensure timely input from sites, and maintain relevant performance
Mentor site-based individuals, contribute to their progress, encourage EU & APAC regulations knowledge for large molecules in Global Q/RA network, engage in Global Q/RA initiatives, improve site & product compliance, promote regulatory services and deliverables for business growth, interact with customers & agencies to develop/implement strategies

Skills

Regulatory Affairs

EU Regulations

APAC Regulations

Large Molecules

Drug Substances

Regulatory Intelligence

Regulatory Compliance

Matrix Management

Mentoring

Regulatory Strategy

CDMO

Biologics

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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