Regulatory Specialist
HeartFlowSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Entry Level & New GradExperience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries
Requirements
Candidates should possess a Bachelor’s degree or equivalent formal academic/vocational qualification, and at least 2+ years of relevant experience. Familiarity with local regulatory guidelines and submission processes is beneficial. Strong communication skills and the ability to work effectively with internal teams and external stakeholders are also required.
Responsibilities
As a Country Approval Specialist, you will prepare, review, and coordinate local regulatory submissions, including those for MoH and EC, ensuring alignment with global submission strategies. You will provide local regulatory strategy advice, coordinate with internal departments to align site start-up activities with submissions, and potentially work with CRAs to prepare compliance review packages. Additionally, you may develop patient information sheets, assist with grant budgets, and maintain trial status information in tracking databases, all while ensuring adherence to PPD SOPs and client directives.
Skills
Regulatory Submissions
Clinical Trial Documentation
Country Approval Process
Regulatory Strategy
Attention to Detail
Documentation Coordination
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