Associate Manager, US Regulatory Affairs

Scorpion Therapeutics; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics in the United States seeks a Senior Associate in Regulatory Affairs to manage and execute regulatory projects supporting cancer therapies, ensuring timely submissions and global compliance. You will prepare INDs, NDAs, and CTD/eCTD publishing, guide cross-functional teams, and maintain regulatory archives, with emphasis on GMP/GCP/ICH guidelines and proactive planning.

Join a fast-paced team focused on innovative cancer treatments, collaborating with clinical, CMC, and

Qualifications

• BA/BS in Health Science or related field.
• 4+ years in pharma/regulatory affairs with experience in INDs, NDAs, amendments, and CTD/eCTD publishing.
• Strong knowledge of FDA and ICH guidelines, GMP, GCP, GLP.
• Excellent communication and planning skills.
• Detail-oriented and self-motivated.

Responsibilities

• Preparing, reviewing, and submitting regulatory dossiers such as INDs, amendments, BLAs/NDAs, and annual reports across clinical, non-clinical, and CMC areas.
• Guiding cross-functional teams on regulatory strategies.
• Maintaining regulatory documentation and archives.

Skills

Regulatory planning

Regulatory submissions

Cross-functional collaboration

Attention to detail

Communication skills

Education

BA/BS in Health Science or related field

Job description

Role

Senior Associate in Regulatory Affairs responsible for managing, evaluating, and executing regulatory projects to support cancer therapies. Primary objectives include ensuring timely regulatory submissions, developing strategies for approvals, and maintaining compliance with global regulatory requirements.

Responsibilities

• Preparing, reviewing, and submitting regulatory dossiers such as INDs, amendments, BLAs/NDAs, and annual reports across clinical, non-clinical, and CMC areas;
• Guiding cross-functional teams on regulatory strategies;
• Maintaining regulatory documentation and archives.

Qualifications

BA/BS in Health Science or related field; 4+ years in pharma/regulatory affairs with experience in INDs, NDAs, amendments, and CTD/eCTD publishing; strong knowledge of FDA and ICH guidelines, GMP, GCP, GLP; excellent communication and planning skills; detail-oriented and self-motivated.

Preferred

Experience with multiple regional regulatory agencies, regulatory strategy development, and working in fast-paced, entrepreneurial environments.

High-Value

Focus on cancer therapeutics, with involvement in investigational and registration stages, compliance with GxP, and collaboration with external consultants/CROs.

Work Setup

Not specified, but implied to be in an environment supporting cross-functional, regulatory activities.