Manager, Regulatory Affairs Operations

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

The Manager Regulatory Affairs Operations is responsible for supporting the preparation, coordination, and submission of regulatory filings to global health authorities, with a focus on U.S. FDA submissions.

Responsibilities

• Collaborate to develop and maintain comprehensive global submission content plans (dossier structure, deliverables, timelines, approval milestones).
• Conduct scenario planning to evaluate regulatory strategies, optimize submission timelines, and mitigate risks.
• Lead coordination and execution of regulatory submissions, including BLAs, INDs, and responses to Health Authority requests.
• Partner with cross-functional teams (CMC, Nonclinical, Clinical, Labeling, etc.) to align submission content and timelines.
• Support preparation, submission, and defense of major U.S. marketing applications (e.g., BLA).
• Participate in and/or lead QC for submissions to ensure accuracy, completeness, and compliance (e.g., eCTD standards) within timelines.
• Manage submission records, documentation, and archiving in RIMS for assigned programs.
• Support transition to and optimization of Veeva RIM (process alignment and user adoption).
• Monitor evolving regulatory requirements and industry trends (e.g., ePublishing/submission standards) and communicate impacts.
• Support management of external vendors (ePublishing providers and regulatory service partners); assist with contract administration (POs and budget monitoring).

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.
• Strong attention to detail, organization, project management; ability to manage multiple competing deadlines.
• Proactive problem-solving; excellent communication and cross-functional collaboration.