Global CMC Regulatory Lead – Small Molecule Drugs

PTC Therapeutics, Inc.; New Jersey; On-site; USD 169,000 - 213,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement savings plans

Short- and long-term incentives

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global CMC strategy for small molecule development and registration.

You will coordinate cross-functionally with Technical Operations, Quality, and Regulatory Affairs to ensure timely, high-quality submissions and lifecycle changes. Experience in IND/CTA, NDA/MAA submissions, eCTDs and post-approval changes is required.

Qualifications

• Hands-on experience in pharmaceutical development, registration and lifecycle management in a global setting.
• Experience preparing regulatory submissions (IND/CTA, NDA/MAA, NDS) and briefing documents.
• Strong understanding of GMP and global regulatory requirements related to CMC.

Responsibilities

• Leads global regulatory CMC strategy for product development and registration.
• Prepares CMC dossiers for small molecule submissions (INDs, NDAs, MAAs) and eCTDs.
• Provides regulatory leadership for lifecycle changes and cross-functional coordination.
• Interacts with regulatory agencies as needed and supports project management.
• Guides internal teams on regulatory guidance and compliance expectations.
• Improves internal processes for writing, reviewing, and reconciling CMC regulatory documents.
• Stays current on CMC regulatory intelligence and industry guidelines.

Skills

GMP environment experience

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Regulatory guidance

Education

Masters or PhD

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global CMC strategy for small molecule development and registration.

You will coordinate cross-functionally with Technical Operations, Quality, and Regulatory Affairs to ensure timely, high-quality submissions and lifecycle changes. Experience in IND/CTA, NDA/MAA submissions, eCTDs and post-approval changes is required.