Senior Associate, Regulatory Affairs

Scorpion Therapeutics; California (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Associate Regulatory Affairs to support global regulatory submissions and interactions for oncology-focused therapeutics, including RAS-targeted inhibitors. You will coordinate documentation with ICH, FDA, and regional guidelines, prepare submissions, and help shape development strategies.

The role emphasizes cross-functional collaboration in a fast-paced biopharma environment, onsite in Redwood City, CA, with a salary range reflecting local market

Qualifications

• Bachelor's degree required.
• 4+ years regulatory experience in drug/biologics companies.
• Familiarity with FDA regulations, ICH guidelines, and regulatory submission processes.
• Proficiency in MS Office and document management systems.
• Eager to develop further regulatory expertise.

Responsibilities

• Coordinate and compile regulatory documentation aligned with ICH, FDA, and regional guidelines.
• Prepare routine submissions.
• Develop and implement SOPs for tracking product events.
• Assess regulatory backgrounds to inform development strategies.
• Stay updated on regulatory changes.
• Collaborate with multidisciplinary teams and represent Regulatory Affairs in project activities.

Education

Bachelor's degree

Tools

MS Office

Document management systems

Job description

Role

Senior Associate Regulatory Affairs supporting global regulatory submissions and interactions at a biopharma focused on oncology therapeutics, specifically RAS-targeted inhibitors.

Responsibilities

• coordinate and compile regulatory documentation aligned with ICH, FDA, and regional guidelines
• prepare routine submissions
• develop and implement SOPs for tracking product events
• assess regulatory backgrounds to inform development strategies
• stay updated on regulatory changes
• collaborate with multidisciplinary teams and represent Regulatory Affairs in project activities

Requirements

• Bachelor's degree
• 4+ years of regulatory experience in drug/biologics companies
• familiarity with FDA regulations, ICH guidelines, and regulatory submission processes
• proficiency in MS Office, document management systems
• eager to develop further regulatory expertise

Preferred experience

• oncology drug development experience
• experience with large, complex submissions like NDAs
• strong communication skills

High Value

Oncology focus, biologics/drugs, development stage not specified, emphasis on regulatory compliance, global submissions, and cross-functional collaboration.

Work Setup

primarily based in Redwood City, CA, salary range $120K-$150K, with considerations for local market; full-time, onsite.