Senior Director, FDA Submissions & Regulatory Compliance

Clinical Dynamix, Inc.; Morristown (NJ); Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

Clinical Dynamix, Inc. in Morristown, NJ seeks an experienced Regulatory Affairs Executive to lead FDA submissions, labeling and state licensing programs, and ensure post‑approval compliance across all products.

The candidate should have 15–20 years in regulatory roles with at least 5 years in an executive capacity, deep FDA knowledge (NDA/BLA, cGMP, CMC), and strong leadership and cross‑functional collaboration. Travel 10–15% is expected.

Qualifications

• 15–20 years of direct regulatory experience in relevant industries.
• Executive-level leadership experience required.
• Strong knowledge of NDA/BLA, FDA rules, cGMP, and labeling/advertising regulations.

Responsabilités

• Lead and oversee FDA submissions and communications.
• Manage labeling development and promotional materials compliance.
• Coordinate state license applications and renewals.
• Collaborate with external counsel and internal stakeholders to ensure regulatory compliance.
• Prepare and maintain regulatory documentation and post‑market reporting.

Connaissances

Regulatory leadership

FDA submissions

Cross-functional leadership

Strategic regulatory planning

Budget management

Description du poste

Clinical Dynamix, Inc. in Morristown, NJ seeks an experienced Regulatory Affairs Executive to lead FDA submissions, labeling and state licensing programs, and ensure post‑approval compliance across all products.

The candidate should have 15–20 years in regulatory roles with at least 5 years in an executive capacity, deep FDA knowledge (NDA/BLA, cGMP, CMC), and strong leadership and cross‑functional collaboration. Travel 10–15% is expected.