Director, Regulatory Affairs - Global Labeling
Gilead SciencesSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Scientific Instruments, Biotechnology, HealthcareIndustries
Requirements
Candidates must possess a high school diploma or equivalent with a relevant vocational qualification and at least 6 years of experience. Three or more years of experience in bid preparation, contract development, or fulfilling RFP requirements is preferred. Strong organizational, planning, and analytical skills are essential, along with proficiency in Microsoft Office and excellent verbal and written communication abilities. The ability to multitask, work under pressure, and interact effectively with clients is also required.
Responsibilities
The Principal Regulatory Affairs Assistant will coordinate data collection and management for proposal and budget development in response to RFPs. This role involves supporting bid and proposal preparation, generating and analyzing data for proposals, contract modifications, and bid defenses. The assistant will also support department management in reporting financial, contractual, and budget data, provide project-specific services and documentation, and coordinate projects. Additionally, this position includes serving as a team lead, training junior members, and reviewing their work.
Skills
Data Management
Metrics Tracking
Proposal Development
Bid Preparation
Contract Management
RFP Analysis
Financial Reporting
Budget Management
Project Coordination
Team Leadership
Training
Microsoft Office Suite
Analytical Skills
Interpersonal Skills
Communication Skills
Multitasking
Attention to Detail
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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