Regulatory Submissions Lead - FDA/BLA/IND

Scorpion Therapeutics; New Jersey; On-site; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager of Regulatory Affairs Operations to support global regulatory submissions with a focus on U.S. FDA programs. You will coordinate content plans, timelines, and lifecycle management, ensuring BLA/IND readiness.

You will partner with CMC, Nonclinical, Clinical, and Labeling teams to align submissions, perform quality checks, and manage records in RIMS, while advancing Veeva RIM adoption and eCTD standards.

Qualifications

• Bachelor's degree in biochemistry, chemistry, biology, or related field (advanced degree preferred: PhD/PharmD/MS).
• 3–5+ years regulatory experience in biotech/pharma (biologics preferred).
• U.S. FDA submission experience (BLA/IND) and strong eCTD knowledge.
• Demonstrated submission planning, coordination, and lifecycle management experience.
• Experience with Regulatory Information Management Systems (Veeva RIM).
• Knowledge of ePublishing processes and vendor coordination.

Responsibilities

• Collaborate to develop and maintain global submission content plans and timelines.
• Lead coordination and execution of regulatory submissions (BLAs, INDs).
• Partner with cross-functional teams to align submission content and timelines.
• Support preparation, submission, and defense of major U.S. marketing applications (e.g., BLA).
• QC submissions for accuracy and compliance within timelines.
• Manage submission records, documentation, and archiving in RIMS.

Skills

Regulatory planning

Cross-functional collaboration

Attention to detail

Project management

Education

Bachelor's degree in biochemistry/related field

PhD/PharmD/MS preferred

Tools

Veeva RIM

eCTD knowledge

ePublishing coordination

Job description

Scorpion Therapeutics is seeking a Manager of Regulatory Affairs Operations to support global regulatory submissions with a focus on U.S. FDA programs. You will coordinate content plans, timelines, and lifecycle management, ensuring BLA/IND readiness.

You will partner with CMC, Nonclinical, Clinical, and Labeling teams to align submissions, perform quality checks, and manage records in RIMS, while advancing Veeva RIM adoption and eCTD standards.