Global Oncology Regulatory Strategy Director

BioSpace; Cambridge (MA); On-site; USD 197,000 - 353,000; Full time

Job summary

Moderna seeks a regulatory leader to drive global strategy from early development to commercialization for oncology programs. You will shape pathways for first‑in‑class therapies and guide cross‑functional teams through complex regulatory processes.

Expect executive-level interaction with health authorities (FDA/EMA/PMDA), strong emphasis on delivering timely submissions and optimizing portfolio strategy. This role demands a track record of approvals and enterprise leadership.

Qualifications

• BA/BS degree in a scientific/engineering discipline.
• 12+ years in the Pharmaceutical industry.
• 8+ years in Regulatory strategy, including oncology.
• Strong knowledge of US and EU regulations and CTD format.

Responsibilities

• Lead global regulatory strategies from early development through commercialization.
• Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence.
• Lead health authority interactions with FDA, EMA, PMDA.
• Shape strategies for novel and first-in-class therapies.
• Partner across functions to align on strategy.
• Mentor regulatory teams and manage stakeholders.

Skills

Regulatory strategy

Leadership

Executive communication

Cross-functional collaboration

Education

BA/BS in a scientific/engineering discipline

Tools

CTD format knowledge

Regulatory filings

FDA/EMA/PMDA interactions

Job description

Moderna seeks a regulatory leader to drive global strategy from early development to commercialization for oncology programs. You will shape pathways for first‑in‑class therapies and guide cross‑functional teams through complex regulatory processes.

Expect executive-level interaction with health authorities (FDA/EMA/PMDA), strong emphasis on delivering timely submissions and optimizing portfolio strategy. This role demands a track record of approvals and enterprise leadership.