Global Regulatory Affairs Director — Submissions & Strategy

Treeline Biosciences; Watertown (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs.

The role requires 8+ years in regulatory affairs, strong FDA/EMA experience, and ability to work cross-functionally in a small, fast-paced environment; advanced degree preferred.

Qualifications

• Bachelor's degree in life sciences or related field is required.
• Minimum 8+ years of regulatory affairs experience in biopharma.
• Experience with global regulatory requirements (FDA/EMA/ICH).
• Strong leadership in developing regulatory strategy and submissions.

Responsibilities

• Lead global regulatory submissions for INDs, NDAs, BLAs and other regulatory applications.
• Oversee regulatory documentation and ensure timelines and compliance across regions.
• Collaborate cross-functionally with Clinical, QA, Pharmacovigilance, and Technical Operations.
• Manage vendor/partner performance and regulatory project plans.
• Interact with regulators and support inspections and correspondence.

Skills

Regulatory strategy

Submissions management

FDA/EMA knowledge

Project management

Cross-functional collaboration

Regulatory inspections

Regulatory filings

Agency communication

Education

Bachelor's degree in life sciences or related field

MS/PhD preferred

Job description

Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs.

The role requires 8+ years in regulatory affairs, strong FDA/EMA experience, and ability to work cross-functionally in a small, fast-paced environment; advanced degree preferred.