Global CMC Regulatory Director (Small Molecules)

PTC Therapeutics, Inc; New Jersey; On-site; USD 169,100 - 212,800; Full time

Benefits offered by this job

Medical, dental, and vision plans

Retirement savings plans

Short- and long-term incentives

Job summary

PTC Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration with Technical Operations and Quality teams. The ideal candidate will have extensive experience in regulatory affairs and a keen understanding of pharmaceutical development.

The position requires strong team collaboration, communication skills, and the ability to prepare regulatory submissions including INDs and NDAs.

Qualifications

• 7-8 years of Regulatory Affairs or CMC technical writing experience in a pharmaceutical environment.
• Experience in preparing regulatory submissions including IND/CTA, NDA/MAA.
• Prior experience within a GMP environment.

Responsibilities

• Lead global regulatory CMC strategy for product development and registration.
• Manage development and preparation of CMC-related submission documents.
• Collaborate on global regulatory CMC strategy and risk mitigation.
• Provide regulatory guidance to cross-functional teams.

Skills

Regulatory submissions preparation

Pharmaceutical development

Technical writing

Influencing skills

Collaboration

Analytical thinking

Communication skills

Microsoft Office proficiency

Education

Bachelor's degree in a scientific discipline

Advanced degree (Masters or PhD)

Job description

PTC Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration with Technical Operations and Quality teams. The ideal candidate will have extensive experience in regulatory affairs and a keen understanding of pharmaceutical development.

The position requires strong team collaboration, communication skills, and the ability to prepare regulatory submissions including INDs and NDAs.