Senior Global Regulatory Strategy Lead, Clinical Trials

Regulatory Toolkit; New Jersey; Hybrid; USD 130,000 - 165,000; Full time

Job summary

PTC Therapeutics is seeking a Senior Manager, Global Clinical Regulatory Lead to provide strategic and operational direction for regulatory activities for PTC drug products in the US and globally where applicable. The role supports Global Regulatory Lead, engages with cross-functional teams, and oversees the US IND submission and clinical trial applications worldwide.

The position collaborates with Regulatory Affairs Strategy, subteams, and CROs.

Qualifications

• Bachelor’s degree in life science field; 5+ years in Pharma/Bio Industry, MS/PhD/PharmD with 3+ years in Regulatory Affairs.
• Knowledge of regional regulatory guidelines and ability to interpret them for assigned projects.
• Experience managing and submitting clinical trial applications and responding to health authority queries.
• Ability to support Global Regulatory Lead with research and tasks outside of filings.
• Proven track record building cross-functional stakeholder relationships.
• Excellent verbal and written communication.
• Ability to work independently and in a fast-paced, matrixed environment.
• Fluent in English (written and spoken). Other languages advantageous.

Responsibilities

• Attend meetings with project teams and stakeholders to ensure effective local product registrations.
• Ensure regulatory compliance for drug and biologic products within the region while supporting business objectives.
• Provide regulatory support to Global Pharmacovigilance and regional representatives.
• Collaborate with Global Regulatory Strategy on regulatory planning and submissions.
• Prepare and review regulatory submissions (IND/CTA, RPDD/ODD, DSURs, etc.).
• Maintain current knowledge of regulations and guidance to develop global regulatory strategies.

Skills

Regulatory affairs

Clinical trials

Stakeholder management

Verbal communication

Written communication

Independent and collaborative work

Analytical thinking

Time management

Education

Bachelor's degree in life science

MS/PhD/PharmD with regulatory experience

Job description

PTC Therapeutics is seeking a Senior Manager, Global Clinical Regulatory Lead to provide strategic and operational direction for regulatory activities for PTC drug products in the US and globally where applicable. The role supports Global Regulatory Lead, engages with cross-functional teams, and oversees the US IND submission and clinical trial applications worldwide.

The position collaborates with Regulatory Affairs Strategy, subteams, and CROs.