Global CMC Regulatory Lead, Small Molecules

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

Benefits offered by this job

Medical, dental, vision, and retirement savings plans

Short and long-term incentives

Job summary

PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global regulatory strategy for product development and registration. This role ensures documentation meets quality standards for small molecule submissions. Qualified candidates will have 7-8 years of experience in Regulatory Affairs or CMC technical writing within a biopharmaceutical setting.

With strong analytical skills, you will manage cross-functional communications and ensure compliance with regulatory requirements. This position offers a competitive base salary and additional incentives.

Qualifications

• Minimum of 7-8 years of Regulatory Affairs experience in pharmaceuticals.
• Experience in translating CMC technical knowledge into regulatory documents.
• Hands-on experience in pharmaceutical development and life cycle management.

Responsibilities

• Lead global regulatory CMC strategy for product development.
• Manage development of CMC-related submission documents.
• Collaborate with Regulatory Affairs Team for submissions and approvals.

Skills

Regulatory Affairs experience

CMC technical writing

Excellent communication skills

Analytical thinking

Proficiency with Microsoft Office

Education

Bachelor's degree in scientific discipline

Advanced academic degree (Masters or PhD)

Job description

PTC Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs – CMC to lead global regulatory strategy for product development and registration. This role ensures documentation meets quality standards for small molecule submissions. Qualified candidates will have 7-8 years of experience in Regulatory Affairs or CMC technical writing within a biopharmaceutical setting.

With strong analytical skills, you will manage cross-functional communications and ensure compliance with regulatory requirements. This position offers a competitive base salary and additional incentives.