VP, Head of Regulatory Affairs

About the Role

Oblenio Bio is seeking a VP, Head of Regulatory Affairs to serve as the company’s strategic regulatory leader during an exciting period of organizational growth. Reporting to the Chief Executive Officer and working in close partnership with the CMO and the broader leadership team, this individual will develop and execute a global regulatory strategy for LBL-051 as the company executes clinical trials on a global scale. This is a unique opportunity to serve as the founding head of regulatory affairs at a well-funded, mission-driven organization with a differentiated asset and a highly experienced team.

Responsibilities

• Develop and lead a comprehensive global regulatory strategy for LBL-051 across all stages of development, including CTA/IND filings and Phase 1/2 clinical development in several geographies.
• Serve as the primary regulatory contact with the FDA and other global health authorities; lead agency interactions including meeting requests, briefing documents, and responses to information requests.
• Oversee preparation and submission of high-quality regulatory documents including CTAs/INDs, amendments, clinical study reports, and responses to health authority questions.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, CMC, Nonclinical, and Commercial Planning/Strategy teams to ensure alignment of regulatory strategy with the overall development program.
• Provide regulatory input into corporate strategy, clinical trial design, protocol development, and study execution.
• Monitor the global regulatory landscape, interpret emerging regulations and guidance documents, and advise leadership on potential implications for the LBL-051 development program.
• Support business development activities, including regulatory due diligence for potential fundraising or strategic transactions.
• Build and manage the regulatory affairs function as the company grows, including oversight of regulatory operations CROs and regulatory consultants.
• Serve as a key member of the senior leadership team, contributing to corporate strategy and positioning the company for near-term milestones, including potential public market entry.

Qualifications

• Bachelor’s degree required; advanced degree (PhD, PharmD, MD, or MS) in a scientific or regulatory discipline preferred.
• Minimum 12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Demonstrated track record of successfully leading regulatory strategy and submissions, including CMC portions, for biologics, preferably antibody-based therapies; experience in immunology/autoimmune indications strongly preferred.
• Experience with IND/CTA preparation and submission; direct experience leading health authority interactions including with FDA, EMA/European country agencies and, ideally NMPA.
• Deep working knowledge of FDA regulations and ICH guidelines; international regulatory experience (EMA and other agencies) a plus.
• Proven ability to lead and influence in a matrixed, cross-functional environment within a small, fast-paced biotech setting.
• Strong written and verbal communication skills; ability to translate complex regulatory concepts for non-regulatory audiences including the C-suite and board.
• Comfort operating in a lean, virtual/remote environment; prior experience as a department head or head of function preferred.
• Track record of building or significantly contributing to a regulatory function from early-stage through clinical development.

Location

This role is intended to be based in Lexington, Massachusetts to work with our team in our established hybrid model in person 2–3 days per week.