Regulatory Specialist
HeartFlowSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Medical DevicesIndustries
Requirements
Candidates should possess a Bachelor's degree in a relevant scientific or regulatory field, and demonstrate at least 5 years of experience in regulatory affairs, specifically within a pharmaceutical or biotechnology environment. Strong knowledge of local regulatory requirements in various countries (such as MoH and EC) is essential, along with the ability to prepare and review regulatory submissions.
Responsibilities
The Country Approval Specialist will prepare, review, and coordinate local regulatory submissions to various agencies, including MoH and EC, in alignment with global submission strategies. They will provide local regulatory strategy advice to internal clients, coordinate SIA projects, act as a key contact for regulatory activities, and ensure alignment of site start-up activities with submission timelines. Additionally, they will support the preparation of regulatory compliance review packages, develop country-specific documents like Patient Information Sheets, and maintain trial status information in tracking databases, all while adhering to PPD SOPs and client directives.
Skills
Regulatory Submissions
Clinical Trial Coordination
Project Management
Regulatory Guidelines
Documentation and Filing
Communication with Investigators
Budget Negotiation
Feasibility 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.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees