Manager, Regulatory Affairs Strategy

Scorpion Therapeutics; United States; Remote; USD 130,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Regulatory Affairs Manager to support late-stage development and registration of therapies for rare diseases. You will lead global regulatory strategies and prepare submissions (INDs, CTAs, NDAs, BLAs) to health authorities.

This role collaborates with Clinical, Nonclinical, CMC, Medical Writing and Project teams to ensure timely regulatory deliverables and lifecycle activities, including post-approval changes. Remote in San Diego with up to 10% travel.

Qualifications

• Bachelor's in Life Sciences required; 6+ years in pharma/biotech regulatory affairs.
• Experience supporting clinical-stage programs and global regulatory compliance.
• Knowledge of FDA, EMA, ICH requirements and health authority interactions.

Responsibilities

• Implement global regulatory strategies for late-stage development.
• Prepare and submit regulatory applications (INDs, CTAs, NDAs, BLAs).
• Lead regulatory documentation efforts and document management.
• Manage interactions with health authorities and regulatory agencies.
• Support lifecycle activities such as post-approval changes.
• Collaborate with Clinical, Nonclinical, CMC, Medical Writing and Project teams to ensure timely deliverables.

Skills

Regulatory strategy

Cross-functional collaboration

Health authority engagement

Education

Bachelor's in Life Sciences

Tools

IND/CTA/ NDA/ BLA submissions

Job description

Role: Regulatory Affairs Manager supporting late-stage development and registration of therapies for rare diseases.

Responsibilities include implementing global regulatory strategies, preparing and submitting applications (INDs, CTAs, NDAs, BLAs), leading regulatory documentation efforts, managing interactions with health authorities, and supporting lifecycle activities like post-approval changes. The role collaborates closely with Clinical, Nonclinical, CMC, Medical Writing, and Project teams, ensuring timely regulatory deliverables and compliance.

Qualifications: Bachelor's in Life Sciences with 6+ years in pharmaceutical/biotech regulatory affairs, experience supporting clinical-stage programs, and knowledge of FDA, EMA, ICH requirements.

Preferred: advanced degrees (MS, PharmD, PhD), experience with Phase 3 and late-stage development, and global post-approval activities.

High-value specifics: focus on rare disease therapies, late-stage regulatory processes, global submissions, and health authority interactions.

Work setup: primarily remote in San Diego with up to 10% domestic and international travel.