Regulatory Submissions Scientist II

SGS Consulting; Sacramento (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting in California is seeking a regulatory submissions specialist to coordinate responses to queries from global authorities on assay development and product performance.

The role emphasizes cross-functional collaboration with Regulatory Affairs, QA, and R&D, and includes maintaining a comprehensive documentation repository and leading project timelines for submissions and post-market activities.

Qualifications

• Minimum 3+ years of relevant experience in regulatory submissions
• Advanced degree in life sciences or chemistry or related field
• Experience coordinating cross-functional teams (Regulatory, QA, R&D)

Responsibilities

• Coordinate and deliver responses to global regulatory questions related to assay development and product performance.
• Collaborate with Regulatory Affairs, Quality, and R&D to gather information for submissions.
• Track and manage activities and deadlines for regulatory submissions and post-market projects.
• Establish a knowledge repository of product data, protocols, and regulatory correspondence.

Skills

3+ years exp

Education

PhD or MS in life sciences/chemistry/biochemistry

Job description

SGS Consulting in California is seeking a regulatory submissions specialist to coordinate responses to queries from global authorities on assay development and product performance.

The role emphasizes cross-functional collaboration with Regulatory Affairs, QA, and R&D, and includes maintaining a comprehensive documentation repository and leading project timelines for submissions and post-market activities.