Associate Director, CMC Regulatory Affairs

PTC Therapeutics, Inc.; Warren Township (NJ); On-site; USD 169,000 - 213,000; Full time

Benefits offered by this job

Short-term incentives

Long-term incentives

Medical insurance

Dental insurance

Vision insurance

Retirement plans

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for product development and registration, and to prepare CMC dossiers for small molecule submissions (INDs and NDAs).

The role collaborates across Regulatory Affairs, Technical Operations, and Quality to deliver high-quality filings on schedule, ensuring compliance with global guidelines and SOPs. Travel up to 10% may be required.

Qualifications

• Minimum 7–8 years in Regulatory Affairs or CMC technical writing in pharma/biotech.
• Experience translating scientific work into regulatory documentation.
• GMP familiarity and knowledge of global regulatory guidance.

Responsibilities

• Lead development and preparation of CMC submissions for small molecule products (NDA/MAA/NDS/INDs).
• Provide global CMC regulatory leadership for lifecycle changes (manufacturing, tech transfer, process improvements).
• Collaborate with Regulatory Affairs to develop global CMC strategy and risk mitigation.
• Manage or assist with regulatory agency interactions.
• Ensure compliant regulatory documentation and adherence to SOPs.

Skills

Regulatory strategy

CMC writing

IND/CTA/NDA submissions

Cross-functional collaboration

ICH regulations

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for product development and registration, and to prepare CMC dossiers for small molecule submissions (INDs and NDAs).

The role collaborates across Regulatory Affairs, Technical Operations, and Quality to deliver high-quality filings on schedule, ensuring compliance with global guidelines and SOPs. Travel up to 10% may be required.