Global Regulatory Affairs Leader - Biotech

ARTBIO

Cambridge (MA)

On-site

USD 260,000 - 400,000

Full time

14 days+

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Job summary

ARTBIO is seeking a Head of Regulatory Affairs to lead the regulatory function for its clinical-stage radiopharmaceutical programs. You will shape strategy, oversee submissions, and engage with health authorities to ensure compliant execution across development and manufacturing.

The role requires 15+ years in biotech/pharma regulatory affairs, an advanced scientific degree, and a proven track record with INDs, NDAs, and MAAs.

Qualifications

Advanced degree in a scientific discipline (JD, PhD, PharmD, MD or equivalent).
15+ years regulatory affairs experience in biotech/pharma with emphasis on drug development.
In-depth knowledge of FDA, EMA and international regulatory frameworks.
Proven track record of regulatory submissions (INDs, NDAs, BLAs, MAAs).
Experience leading regulatory strategies for complex programs across multiple therapeutic areas.
Strong understanding of drug development, CMC, quality, and clinical trial regulations.
Familiarity with radiopharmaceuticals is a plus.

Responsibilities

Define and lead global regulatory strategy for ARTBIO’s clinical-stage radiopharmaceutical programs.
Lead regulatory submissions, including INDs, CTAs, and DMFs.
Lead FDA and global health authority interactions, including meeting preparation and follow-up actions.
Ensure regulatory compliance across the drug development lifecycle, including trials and manufacturing.
Identify regulatory risks and develop mitigation strategies.
Partner with cross-functional teams to support timely, high-quality submissions.
Serve as primary contact for regulatory agencies and build external relationships.