Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor's degree or equivalent formal academic/vocational qualification and at least two years of relevant experience. Previous experience demonstrating knowledge of regulatory requirements and guidances for document management and electronic submissions is required. Familiarity with Microsoft Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, and electronic templates is also necessary.
The Reg Publishing Spec will coordinate and manage client electronic submission deliverables to support regulatory compliance, assist in preparing electronic document outputs that meet regulatory requirements, ensure that all final electronic deliverables meet current regulatory electronic document requirements, assist with developing and implementing project-specific processes for sponsors, evaluate publishing needs in relation to project timelines and quality, engage other team members to deliver final products and resolve issues, and act independently within a project team to evaluate and deliver publishing tasks. They will also serve in a quality review role, thoroughly reviewing documents to ensure quality meets or exceeds client expectations and may act as the company's liaison for electronic submissions with the sponsor.
Provides life sciences products and services
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.