Senior Manager, CMC Regulatory Affairs - Small Molecules

Scorpion Therapeutics; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Manager, CMC Regulatory Affairs to lead strategic and operational CMC activities supporting small molecule drug development and commercialization, primarily oral solid dosage forms such as tablets and capsules.

You will oversee regulatory strategies across development stages from IND through post-approval, coordinating with cross-functional teams to enable timely approvals and lifecycle management in a remote-based role with travel.

Qualifications

• 7+ years in pharmaceutical/biotech regulatory affairs with substantial small molecule CMC experience.
• Proven track record supporting oral solid dosage form development and lifecycle management.
• Experience with FDA, EMA, PMDA, GCC regulatory authorities.

Responsibilities

• Develop and execute CMC regulatory strategies across development stages from IND through post-approval.
• Lead regulatory submissions including INDs, NDAs, amendments, and lifecycle management activities.
• Serve as the primary regulatory interface on cross-functional teams with Pharmaceutical Development, Manufacturing, Quality, and Regulatory Operations.
• Assess regulatory risks and develop mitigation strategies.
• Support regulatory inspections and responses.
• Guide post-approval CMC change strategies.

Skills

Regulatory strategy

Leadership

Strategic thinking

Cross-functional collaboration

Education

Bachelor's degree in pharmaceutical sciences, chemistry, or related field

Job description

Role

Senior Manager, CMC Regulatory Affairs, provides strategic and operational leadership for Chemistry, Manufacturing, and Controls activities supporting small molecule drug development and commercialization, primarily oral solid dosage forms such as tablets and capsules.

Responsibilities

• develop and execute CMC regulatory strategies across development stages from IND through post-approval
• lead regulatory submissions including INDs, NDAs, amendments, and lifecycle management activities
• serve as the primary regulatory interface on cross-functional teams collaborating with Pharmaceutical Development, Manufacturing, Quality, and Regulatory Operations
• assess regulatory risks and develop mitigation strategies
• support regulatory inspections and responses
• guide post-approval CMC change strategies

Requirements

• Bachelor's degree in pharmaceutical sciences, chemistry, or related field
• 7+ years in pharmaceutical/biotech regulatory affairs with substantial experience in small molecule CMC
• proven track record supporting oral solid dosage form development, process validation, and lifecycle management
• experience with global regulatory authorities (FDA, EMA, PMDA, GCC)
• strong leadership, strategic thinking, and cross-functional collaboration skills

High-Value

• extensive experience in CMC submissions, lifecycle management, manufacturing process development, and global regulatory interactions
• supporting small molecule oral dosage forms from IND to post-market phases
• experience with regulatory strategies for manufacturing changes and technology transfers
• ability to operate independently and lead complex projects

Work Setup

Remote-based in San Diego, with approximately 10% domestic and international travel; face-to-face collaboration expected as needed.