Associate Director, Regulatory Affairs - CMC

PTC Therapeutics, Inc.; United States; On-site; USD 135,000 - 195,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Regulatory Affairs - CMC to drive global regulatory strategy for small molecule drug programs. You will oversee CMC documentation, lifecycle management, and post-approval changes while coordinating with Regulatory Affairs, Technical Operations, and Quality teams.

You will manage agency interactions and ensure adherence to GMP and ICH standards across regions, with travel up to 20% as needed for global filings and inspections.

Qualifications

• Bachelor's in a scientific discipline with 7-8+ years in Regulatory Affairs or CMC writing.
• Deep knowledge of small molecule development, GMP, ICH regulations, and global processes.
• Proven submissions experience and lifecycle change management.
• Strong collaboration, communication, and project management.

Responsibilities

• Oversee preparation of CMC documentation for filings (NDAs, INDs, MAAs).
• Lead lifecycle management and post-approval change strategies.
• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, and Quality teams.
• Manage agency interactions and ensure regulatory compliance.

Skills

Regulatory strategy

CMC knowledge

Global regulatory processes

Project management

Cross-functional collaboration

Education

Bachelor's in a scientific discipline

Advanced degree (Masters/PhD)

Job description

Role

Associate Director, Regulatory Affairs - CMC, leading global regulatory strategy for small molecule drug development and registration.

Responsibilities

• oversee preparation of CMC documentation for filings such as NDAs, INDs, and MAAs
• lead lifecycle management and post-approval change strategies
• collaborate cross-functionally with Regulatory Affairs, Technical Operations, and Quality teams
• manage agency interactions
• ensure compliance with global regulatory guidance and industry standards

Requirements

• Bachelor's in a scientific discipline, 7-8+ years’ experience in Regulatory Affairs or CMC technical writing within pharma/biotech
• deep knowledge of small molecule development, GMP, ICH regulations, and global regulatory processes
• proven experience in preparing submissions and managing lifecycle changes
• strong collaboration, communication, and project management skills

Preferred

• advanced degree (Masters or PhD)
• experience in non-ICH regions
• knowledge of regulatory aspects beyond CMC

HighValue

• small molecules
• global regulatory environment
• lifecycle management
• IND/CTA/NDA/MAA submissions
• up to 20% travel

WorkSetup

remote with up to 20% travel.