Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor's degree or equivalent formal academic/vocational qualification, along with at least 5 years of relevant experience. A strong understanding of regulatory requirements and guidances for document management and electronic submissions is essential, as is advanced knowledge of Microsoft Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, and advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates.
The Regulatory Publishing Specialist will prepare components of electronic regulatory submissions to meet regulatory requirements, maintain document life cycles for submission documents, lead the development and implementation of project-specific processes for sponsors, and potentially act as the company’s liaison for regulatory submissions with sponsors and assist project teams in executing regulatory submission strategies, providing leadership through training and mentoring, using professional judgment to evaluate publishing needs, engaging with project teams to deliver final products and resolve issues, and working independently or as a project team lead to evaluate and deliver publishing tasks.
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.