Director/Senior Director, Global Regulatory Affairs

Meet Life Sciences; Boston (MA); Vor Ort; USD 150.000 - 200.000; Vollzeit

Zusammenfassung

Meet Life Sciences is seeking a Director / Senior Director, Global Regulatory Lead in Boston, MA to drive regulatory strategy across oncology programs. The ideal candidate will lead NDA submissions and collaborate with various teams, leveraging over 10 years of regulatory affairs experience. The role offers a hybrid work model, requiring 3 days in the office each week, with relocation support provided. A Bachelor’s degree is essential, with a preference for advanced degrees and oncology experience.

Qualifikationen

• 10+ years of regulatory affairs experience within biotech/pharma.
• Recent, hands-on oncology NDA/BLA submission experience required.
• Proven leadership experience with the ability to influence cross-functional teams.

Aufgaben

• Lead global regulatory strategy for oncology programs from late-stage development through approval.
• Serve as the regulatory lead for NDA/BLA submissions, including planning and execution.
• Act as the primary point of contact with global health authorities.

Kenntnisse

Regulatory strategy

NDA/BLA submissions

Leadership

Regulatory requirements knowledge

Cross-functional collaboration

Ausbildung

Bachelor’s degree

Advanced degree (PhD, PharmD, MS)

Jobbeschreibung

Title: Director / Senior Director, Global Regulatory Lead

Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!)

Overview

A growing oncology biotech is seeking a Director / Senior Director, Global Regulatory Lead to drive global regulatory strategy across clinical-stage oncology programs. This individual will play a critical role in leading the company’s first NDA submission and partnering closely with executive leadership to advance assets toward approval.

Key Responsibilities

• Lead global regulatory strategy for oncology programs from late-stage development through approval
• Serve as the regulatory lead for NDA/BLA submissions, including planning, execution, and submission readiness
• Partner cross-functionally with Clinical, CMC, Commercial, and Executive Leadership teams
• Act as the primary point of contact with global health authorities (e.g., FDA, EMA)
• Provide strategic input on regulatory risks, timelines, and pathways
• Oversee regulatory documentation, including briefing books, submission dossiers, and responses to agency queries

Qualifications

• Bachelor’s degree required; advanced degree (PhD, PharmD, MS) preferred
• 10+ years of regulatory affairs experience within biotech/pharma
• Recent, hands-on oncology NDA/BLA submission experience required
• Strong knowledge of global regulatory requirements and pathways
• Proven leadership experience with the ability to influence cross-functional teams
• Experience in a fast-paced or emerging biotech environment preferred