Global Regulatory Affairs Director: Strategy & Submissions (Hybrid)

Clinical Dynamix, Inc.; Jersey City (NJ); Hybrid; USD 210,000 - 320,000; Full time

Job summary

Clinical Dynamix, Inc. in New Jersey seeks a Senior Director, Regulatory Affairs to lead global regulatory strategy, guide FDA submissions and lifecycle management for medical products.

Hybrid work arrangement in Northern NJ is available. The ideal candidate has 15+ years in regulatory affairs, an advanced life sciences degree, and a proven capability to direct policy, regulatory intelligence, and cross-functional collaboration with external partners.

Qualifications

• 15+ years of progressive experience in regulatory affairs with global scope.
• Mastery of global regulatory agencies, processes and regulations.
• Proven record of medical product filings (INDs, NDAs, BLAs, MAAs).
• Excellent writing and verbal communication; ability to influence stakeholders.

Responsibilities

• Secure US and global regulatory marketing authorization for new products and updates.
• Lead preparation, review and submission of regulatory documents to FDA and regulators.
• Develop and implement policies, processes and SOPs for regulatory affairs.
• Formulate regulatory strategies for pipeline products and lifecycle management.
• Monitor regulatory updates and provide training on requirements.
• Maintain licenses, registrations and listings; act as SME on regulatory matters.
• Represent company in external meetings with regulators and development partners.

Skills

Regulatory leadership

Global regulatory knowledge

Regulatory submissions

Effective communication

Education

PharmD/PhD/MD/MA in Life Sciences

Job description

Clinical Dynamix, Inc. in New Jersey seeks a Senior Director, Regulatory Affairs to lead global regulatory strategy, guide FDA submissions and lifecycle management for medical products.

Hybrid work arrangement in Northern NJ is available. The ideal candidate has 15+ years in regulatory affairs, an advanced life sciences degree, and a proven capability to direct policy, regulatory intelligence, and cross-functional collaboration with external partners.