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

Job Responsibilities

• Regulatory Submission Support:Coordinate and deliver timely, informed responses to global regulatory authorities’ questions related to assay development and product performance.Collaborate cross-functionally with Regulatory Affairs, Quality, and R&D teams to gather and synthesize necessary information for submissions.
• Project Management:Track and manage activities and deadlines related to regulatory submissions and post-market support projects.Maintain project timelines and communicate status updates to stakeholders.
• Product Knowledge Repository:Establish and maintain a comprehensive repository of product knowledge, including technical documentation, study data, protocols, and regulatory correspondence.Ensure the repository is organized, accessible, and up-to-date for internal use.
• Documentation Strategy:Assess current documentation and design history files for completeness and regulatory readiness.Make recommendations and develop strategic plans to address gaps, including proposing new study plans, protocols, and documentation updates.Partner with subject matter experts to drive documentation improvements and ensure compliance with global regulatory requirements.

Skills

• 3+ years of experience

Education/Experience

• PhD or MS in life sciences, chemistry, biochemistry, or related field (or equivalent experience).