VP Regulatory Strategy & Submissions (FDA)

Clinical Dynamix, Inc.; Florham Park (NJ); On-site; USD 260,000 - 380,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a Vice President of Regulatory Strategy to lead regulatory planning and submissions from pre-submission to approval. You will drive regulatory strategy across product candidates and collaborate with R&D, quality, operations, and legal to ensure compliant, timely approvals.

The role includes exposure to US FDA leadership, global regulatory strategy, and oversight of IP activities with cross-site manufacturing teams. Strong leadership and strategic vision are essential.

Qualifications

• Minimum 15 years in regulatory affairs or pharmaceutical regulatory strategy.
• Executive leadership experience in major pharma or biotech.
• Extensive experience with FDA submissions, including ANDAs/NDAs.
• Proven ability to lead cross-functional teams and manage budgets.

Responsibilities

• Lead regulatory affairs team and provide strategic direction.
• Coordinate with R&D, Quality, Manufacturing, and Legal to ensure lifecycle regulatory compliance.
• Serve as US FDA primary contact and develop regulatory strategies.
• Mentor staff on FDA expectations and evolving regulatory landscape.
• Oversee regulatory staff workload and performance.

Skills

Regulatory leadership

FDA interface

Cross-functional leadership

Regulatory strategy

Budget management

Team development

Quality systems knowledge

Education

Bachelor's degree

Graduate degree preferred

Tools

CMC knowledge

Job description

Clinical Dynamix, Inc. seeks a Vice President of Regulatory Strategy to lead regulatory planning and submissions from pre-submission to approval. You will drive regulatory strategy across product candidates and collaborate with R&D, quality, operations, and legal to ensure compliant, timely approvals.

The role includes exposure to US FDA leadership, global regulatory strategy, and oversight of IP activities with cross-site manufacturing teams. Strong leadership and strategic vision are essential.