Executive Director Global Regulatory Affairs Position Available In Essex, New Jersey

Executive Director Global Regulatory Affairs EPM Scientific – 3.3 Newark, NJ Job Details Full-time $270,000 – $350,000 a year 6 hours ago Qualifications Doctoral degree 11+ years Master’s degree Bachelor’s degree Doctor of Philosophy EMR systems Pharmacy Senior level Leadership Communication skills

Marketing Negotiation Full Job Description Title:

Executive Director Global Regulatory Affairs A leading global biopharmaceutical organization is seeking a seasoned Executive Director of Global Regulatory Strategy to lead regulatory initiatives across a diverse portfolio of innovative therapies. This is a high-impact, hands-on leadership role ideal for a strategic thinker with deep regulatory expertise and a passion for advancing global health.

Responsibilities:

Provide strategic regulatory leadership for global development programs and marketed products across designated therapeutic areas. Lead and mentor a team of regulatory professionals in the development and execution of global regulatory strategies. Serve as the senior regulatory representative on cross-functional project teams throughout the product lifecycle. Advise executive leadership on U.S. and international regulatory matters, ensuring alignment with evolving global standards. Oversee planning and execution of regulatory agency interactions, including meetings with major health authorities (e.g., FDA, EMA, PMDA). Actively participate in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and development of corrective actions. Support regulatory inspections and audits, including response development and implementation of corrective actions. Monitor and interpret global regulatory trends, providing strategic insights and direction on emergency policy & regulatory intelligence. Drive continuous improvement in regulatory processes and team performance. Manage timelines, budgets, and resource planning for regulatory programs. Contribute to global regulatory policy initiatives and cross-functional governance committees. Qualifications Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, or equivalent) preferred. Minimum of 12 years of industry experience, including at least 10 years in regulatory affairs within the biopharma sector. Proven leadership experience managing regulatory teams and complex global submissions. Demonstrated success in leading regulatory strategy for major marketing applications (e.g., NDA, BLA, MAA). Strong track record of engagement with global regulatory agencies (FDA, EMA) and successful negotiation of regulatory pathways. Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada). Strategic mindset with the ability to navigate ambiguity and make informed decisions. Excellent communication and presentation skills, with the ability to influence at all levels of the organization.