Thermo Fisher Scientific

Reg Affairs AD, FSP

Sofia, Sofia City Province, Bulgaria

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$60,000 – $90,000Compensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Regulatory AffairsIndustries

Requirements

Candidates should possess a Bachelor’s degree in a relevant scientific or regulatory field, along with a minimum of 8 years of Regulatory Affairs experience, specifically within the pharmaceutical or scientific services industry. Strong leadership and management skills are required, including experience in supervising and developing a team of staff and managers. Familiarity with global regulatory requirements, particularly those related to clinical trials and product registration, is essential.

Responsibilities

This role involves managing a team of regulatory staff, providing regulatory consulting and strategic advice to clients, overseeing project budgets and forecasting, ensuring compliance with SOPs and WPDs, collaborating with business development on new business opportunities, and contributing to the development and implementation of global/regional function plans. The Reg Affairs AD will also manage project timelines, identify out-of-scope activities, and lead the development of processes and procedures to improve team productivity and accuracy.

Skills

Regulatory Affairs

Clinical Trials

Product Registration

Global Regulatory Requirements

SOPs

WPDs

Project Management

Team Leadership

Strategic Consulting

Budget Forecasting

Process Development

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.

Key Metrics

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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