Global Regulatory Affairs Director - Submissions & Strategy

Treeline; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Treeline is seeking an Associate Director / Director of Regulatory Affairs to lead global regulatory activities within our clinical team. This hands-on role oversees regulatory submissions, strategy development, and regulatory compliance, interfacing with agencies and internal stakeholders to streamline filings.

The ideal candidate has extensive regulatory experience in biopharma (oncology preferred), across FDA/EMA/ICH, with strong communication and project-management skills to thrive in a

Qualifications

• 8+ years of regulatory affairs experience in biopharma, oncology preferred.
• Experience with FDA/EMA/ICH across preclinical and clinical stages.
• EU and ex-US regulatory experience (CTAs, MAAs, PIPs, etc.).
• Strong communication and collaboration with internal teams and regulators.
• Experience with inspections, audits, and agency interactions.
• Experience contributing to regulatory strategies for complex products.

Responsibilities

• Prepare and submit regulatory submissions (INDs, NDAs, BLAs) on time.
• Ensure compliance with FDA and global health authority specs.
• Collaborate with Clinical Operations, QA, Pharmacovigilance, and others.
• Manage third-party vendors and regulatory publishing.
• Provide project management support for regulatory and clinical projects.
• Maintain relationships with regulatory agencies (FDA/EMA).
• Develop SOPs and quality control measures for compliance.
• Plan and report regulatory milestones using PM tools.
• Contribute to regulatory strategy plans aligned with clinical timelines.
• Stay updated on evolving requirements and industry trends.
• Support regulatory budgets, resources, and timelines.

Skills

Regulatory affairs

Cross-functional collaboration

Project management

Regulatory submissions

Communication

Attention to detail

Education

Bachelor's degree in life sciences or related field

MS/PhD preferred

Job description

Treeline is seeking an Associate Director / Director of Regulatory Affairs to lead global regulatory activities within our clinical team. This hands-on role oversees regulatory submissions, strategy development, and regulatory compliance, interfacing with agencies and internal stakeholders to streamline filings.

The ideal candidate has extensive regulatory experience in biopharma (oncology preferred), across FDA/EMA/ICH, with strong communication and project-management skills to thrive in a