Director, Regulatory Affairs - Global Labeling
Gilead SciencesSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Entry Level & New Grad, Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries
Requirements
Candidates should possess a Bachelor's degree or equivalent, with 0-2 years of relevant experience. Effective communication, interpersonal, and negotiation skills are necessary, along with strong attention to detail and computer proficiency. Basic knowledge of medical terminology and regulatory guidelines is also required.
Responsibilities
The Associate Country Approval Specialist will prepare, review, and coordinate country and local ethics committee submissions in alignment with global strategies. They will support the preparation of Ministry of Health submissions, coordinate with internal departments for site start-up activities, and ensure alignment with critical path timelines. The role involves maintaining trial status information, ensuring local country study files are prepared and maintained, and staying updated on PPD and client SOPs and regulatory guidelines.
Skills
Country Submissions
MoH submissions
Clinical Trials
Regulatory Submissions
Documentation
Coordination
Communication
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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