Global CMC Regulatory Director - Submissions & Strategy

Regulatory Jobs; United States; Presencial; USD 169.000 - 213.000; Tempo integral

Benefícios oferecidos por esta vaga

Short- and long-term incentives

Medical, dental, vision, and 401(k)

Resumo da vaga

PTC Therapeutics is seeking an Associate Director, Regulatory Affairs – CMC to lead global CMC strategy for product development and regulatory submissions. You will coordinate with Regulatory Affairs, Technical Operations and Quality to ensure high-quality CMC documentation and alignment with timelines.

The role requires 7–8+ years in Regulatory Affairs/CMC writing, experience with INDs and NDAs, and advanced degree consideration. Travel up to 20% may apply.

Qualificações

• Bachelor's degree in a scientific field; advanced degree preferred.
• 7-8+ years regulatory affairs and/or CMC writing experience.
• Experience with global regulatory submissions (INDs/NDAs/MAAs) and post‑approval lifecycle.
• GMP knowledge and familiarity with ICH/regulatory guidelines.

Responsabilidades

• Lead global regulatory CMC strategy for small molecules and submissions.
• Prepare CMC dossiers including eCTDs for regulatory filings.
• Guide lifecycle changes to ensure supply continuity and global compliance.
• Collaborate with Regulatory Affairs, Technical Operations and Quality.
• Support regulatory agency interactions and responses to queries.
• Improve internal processes for CMC documentation and accuracy.

Conhecimentos

Regulatory affairs

Regulatory writing

Cross-functional collaboration

Communication skills

Analytical thinking

Formação

Bachelor's degree in scientific discipline

Master's or PhD (advanced degree)

Ferramentas

eCTD preparation

MS Office

Descrição da vaga

PTC Therapeutics is seeking an Associate Director, Regulatory Affairs – CMC to lead global CMC strategy for product development and regulatory submissions. You will coordinate with Regulatory Affairs, Technical Operations and Quality to ensure high-quality CMC documentation and alignment with timelines.

The role requires 7–8+ years in Regulatory Affairs/CMC writing, experience with INDs and NDAs, and advanced degree consideration. Travel up to 20% may apply.