Global Clinical Regulatory Strategy Lead

PTC Therapeutics, Inc.; New Jersey; Hybrid; USD 130,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plans

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Global Clinical Regulatory Lead to provide strategic direction for regulatory activities for US clinical and commercial products.

You will oversee IND submissions in the US and CTAs globally, collaborating with Regulatory Affairs Strategy, subteams, and cross-functional teams. You will liaise with external partners, ensure compliance with SOPs, and guide regulatory strategy throughout development and lifecycle management.

Qualifications

• Bachelor’s degree; 5+ years in Pharma/Bio Industry; advanced degree preferred.
• Knowledge of regional regulatory guidelines and interpretation for projects.
• Experience submitting CTAs/INDs and responding to health authorities.
• Ability to support Global Regulatory Lead; cross-functional collaboration.

Responsibilities

• Collaborate with project teams to ensure local product registrations.
• Support regulatory submissions for US and international projects.
• Prepare and review regulatory documents (INDs, DSURs, RPDD/ODD).
• Maintain knowledge of regulations and provide strategic direction.
• Liaise with CROs and internal teams on timelines.

Skills

Regulatory affairs

Regulatory submissions

Cross-functional coordination

Communication skills

English fluency

Education

Bachelor’s degree in life science

MS/PhD/PharmD in Regulatory Affairs

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Global Clinical Regulatory Lead to provide strategic direction for regulatory activities for US clinical and commercial products.

You will oversee IND submissions in the US and CTAs globally, collaborating with Regulatory Affairs Strategy, subteams, and cross-functional teams. You will liaise with external partners, ensure compliance with SOPs, and guide regulatory strategy throughout development and lifecycle management.