Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess a high school diploma or equivalent qualification, along with at least two years of prior experience in the pharmaceutical or CRO industry, and potentially a certificate. Familiarity with clinical and non-clinical regulatory documents, advanced Word formatting skills, and Veeva experience are preferred qualifications.
The Regulatory Affairs Assistant will provide administrative support to the department, including travel arrangements, expense coordination, meeting planning, and presentation preparation. They will manage the document archiving and retrieval process, maintain archive areas, assist in the management of SOPs/WPDs, assist with webpage maintenance, and support the maintenance of utilization/resourcing tools, as well as archiving of documents and submissions.
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.