Global Regulatory Strategy Director

Beeline Medicines Corporation; Boston (MA); Hybrid; USD 250,000 - 360,000; Full time

Benefits offered by this job

Discretionary annual bonus

Long‑term incentive equity

Job summary

Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management.

Hybrid work with on-site days is expected, and the candidate will guide cross‑functional teams to ensure timely approvals. The position requires a PhD/PharmD/Master with 15+ years in Regulatory Affairs, including 5+ years as Global Regulatory Lead, and strong

Qualifications

• Advanced degree in life sciences required.
• 15+ years regulatory affairs experience; at least 5 years as Global Regulatory Lead.
• Hands‑on experience with CTA, NDA, MAAs, briefing books, and health authority responses.
• Immunology experience preferred.
• Experience negotiating with FDA/EMA and other authorities.
• Proven track record leading global marketing applications from submission to approval.

Responsibilities

• Develop global regulatory strategies and serve as the Global Regulatory Leader for assigned Regulatory Project Teams.
• Direct and coordinate regulatory strategy and execution of INDs, CTAs, NDAs, MAAs and health authority interactions.
• Provide regulatory guidance, assess risks, and communicate updates to senior leadership.
• Lead global regulatory submissions, lifecycle management, and health authority interactions.
• Ensure compliance with US, EU, ICH, and other regulatory requirements.
• Manage timelines, documents, contractors, and future direct reports with urgency and accountability.
• Disseminate regulatory intelligence and collaborate with cross‑functional partners.

Skills

Global regulatory leadership

Regulatory strategy

FDA/EMA negotiations

Regulatory submissions

Cross-functional leadership

Team mentoring

Education

Advanced life sciences degree

Tools

IND/CTA filings

NDA/MAA submissions

Job description

Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management.

Hybrid work with on-site days is expected, and the candidate will guide cross‑functional teams to ensure timely approvals. The position requires a PhD/PharmD/Master with 15+ years in Regulatory Affairs, including 5+ years as Global Regulatory Lead, and strong