Global Regulatory CMC Director - Biologics

PTC Therapeutics, Inc; New Jersey; On-site; USD 194,000 - 244,000; Full time

Benefits offered by this job

Incentives

Health/dental/vision

Retirement plan

Job summary

PTC Therapeutics, Inc. is seeking a Director, Regulatory Affairs - CMC to lead global CMC strategy for biologics development, registration and post-approval lifecycle management.

You will guide cross-functional teams across Regulatory Affairs, Technical Operations and Quality to prepare high-quality CMC submissions for INDs, BLAs and MAAs. The role requires deep regulatory expertise in GMP environments, ICH guidelines, and experience with gene/cell therapies.

Qualifications

• Bachelor's degree in a scientific discipline and 8–10 years in Regulatory Affairs CMC.
• Experience with biologics; gene/cell therapies a plus.
• GMP experience and ICH knowledge.
• Ability to manage global CMC submissions (IND/CTA, BLA/NDA/MAA, etc).

Responsibilities

• Leads development of global regulatory CMC strategy and risk management to enable submissions and approvals.
• Leads preparation of CMC-related submission documents for biologics (e.g., gene therapy) to ensure high-quality documents for regulatory review.
• Manages regulatory agency interactions related to CMC.
• Interprets regulatory guidance and provides cross-functional recommendations.
• Supports development of internal processes to improve CMC in regulatory documents.

Skills

Regulatory strategy

Global submissions

Biologics knowledge

Education

Bachelor's degree in a scientific discipline

Master's degree or PhD (advantage)

Job description

PTC Therapeutics, Inc. is seeking a Director, Regulatory Affairs - CMC to lead global CMC strategy for biologics development, registration and post-approval lifecycle management.

You will guide cross-functional teams across Regulatory Affairs, Technical Operations and Quality to prepare high-quality CMC submissions for INDs, BLAs and MAAs. The role requires deep regulatory expertise in GMP environments, ICH guidelines, and experience with gene/cell therapies.