Senior Manager, Global Clinical Regulatory Lead
PTC Therapeutics · Warren, NJ
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Role summary
PTC Therapeutics seeks a Senior Manager to lead global clinical regulatory strategy and execution for drug products across US and international markets. This role oversees IND submissions, clinical trial applications, regional registrations, and lifecycle management activities while collaborating with cross-functional teams and external partners to ensure compliance with regulatory requirements.
What they're looking for
- Bachelor's degree in life science or equivalent advanced degree (MS, PhD, PharmD)
- Minimum 5 years pharma/biotech industry experience or 3 years regulatory affairs experience
- Hands-on experience managing and submitting clinical trial applications across development phases
- Knowledge of regional regulatory guidelines and ability to interpret requirements for assigned projects
- Strong stakeholder relationship building and cross-functional team collaboration skills
- Excellent verbal and written communication in English; additional languages advantageous
- Analytical thinking with problem-solving ability in fast-paced, matrixed environments
What you'll be doing
- Oversee IND submissions in the US and clinical trial applications globally
- Develop and maintain global regulatory strategies for drugs and gene therapies
- Prepare regulatory submissions including CCDS, labeling documents, CTAs, and safety reports
- Collaborate with cross-functional teams, CROs, and health authorities on clinical trial applications
- Support Global Regulatory Lead on product life cycle management and regional registration execution
Privacy & handoff
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