Global Regulatory CMC Lead

Regulatory Jobs; United States; On-site; USD 169,000 - 213,000; Full time

Benefits offered by this job

Incentives

Medical insurance

Retirement plan

Job summary

PTC Therapeutics is seeking an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for small molecule programs and to prepare CMC dossiers (INDs and NDAs) across regions.

You will collaborate with Regulatory Affairs, Technical Operations, Quality and Submission Project teams to ensure compliant filings and lifecycle regulatory support, while driving timely approvals.

Qualifications

• 7–8+ years Regulatory Affairs experience or CMC writing in pharma/biotech.
• Advanced degree a plus.

Responsibilities

• Lead and prepare CMC submission documents for small molecules (NDA/MAA/NDS) and related eCTDs.
• Drive global post‑approval CMC regulatory strategies for lifecycle changes to ensure supply continuity.
• Collaborate with Regulatory Affairs to develop robust global CMC strategy and risk mitigation.
• Manage or support regulatory agency interactions.
• Provide regulatory guidance to cross‑functional teams on complex scientific issues.

Skills

Regulatory Affairs

CMC Writing

Global Submissions

IND/CTA/NDAs

Cross-functional Leadership

GMP Knowledge

ICH Regulations

Regulatory Strategy

Regulatory Agency Interactions

Writing & Communication

Education

Masters or PhD preferred

Tools

Microsoft Office

Job description

PTC Therapeutics is seeking an Associate Director, Regulatory Affairs – CMC to lead global regulatory CMC strategy for small molecule programs and to prepare CMC dossiers (INDs and NDAs) across regions.

You will collaborate with Regulatory Affairs, Technical Operations, Quality and Submission Project teams to ensure compliant filings and lifecycle regulatory support, while driving timely approvals.