Senior Global Regulatory Lead: Clinical Trials Strategy

PTC Therapeutics, Inc; Warren Township (NJ); Hybrid; USD 130,000 - 165,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Retirement savings plan

Incentives (short- and long-term)

Job summary

PTC Therapeutics is seeking a Senior Manager, Global Clinical Regulatory Lead to provide strategic direction for regulatory activities for US clinical and commercial drug products, and support global regulatory trials and lifecycle management.

The role coordinates with Regulatory Affairs Strategy, subteams, and cross-functional teams, overseeing US IND submissions and global regulatory strategy execution. Hybrid work with on-site visits in Warren, NJ.

Qualifications

• Bachelor’s degree in life science field; MS/PhD/PharmD with regulatory experience considered an asset.
• Experience managing and submitting clinical trial applications (IND/CTA) and regulatory filings.
• Excellent verbal and written communication; ability to work in a fast-paced, matrixed environment.

Responsibilities

• Collaborates with project teams and stakeholders to ensure effective local product registrations.
• Supports US IND submissions and global regulatory strategy alignment with GRLs and cross-functional teams.
• Prepare and review regulatory submissions (IND/CTA, RPDD, ODD, DSURs, and other regulatory documents).
• Maintain up-to-date knowledge of regulatory requirements and provide strategic direction to regulatory activities.

Education

Bachelor's degree in life science field

MS/PhD/PharmD with minimum 3 years Regulatory Affairs experience

Job description

PTC Therapeutics is seeking a Senior Manager, Global Clinical Regulatory Lead to provide strategic direction for regulatory activities for US clinical and commercial drug products, and support global regulatory trials and lifecycle management.

The role coordinates with Regulatory Affairs Strategy, subteams, and cross-functional teams, overseeing US IND submissions and global regulatory strategy execution. Hybrid work with on-site visits in Warren, NJ.