VP, Global Regulatory Strategy

Oblenio Bio, Inc.; Lexington (MA); Hybrid; USD 250,000 - 350,000; Full time

Job summary

Oblenio Bio is seeking a VP, Head of Regulatory Affairs to lead the global regulatory strategy for LBL-051, guiding clinical development and near-term milestones in a hybrid work setting. Reporting to the CEO and partnering with the CMO and leadership team, you will manage FDA interactions, prepare CTAs/INDs, and build a scalable regulatory function as the company grows.

This role combines strategic oversight with hands-on execution in a lean, fast-moving biotech, with potential for public

Qualifications

• Minimum 12+ years of regulatory affairs experience in the biopharmaceutical industry.
• Proven track record leading regulatory submissions (CMC) for biologics.
• Experience with IND/CTA preparation and health authority interactions, including FDA/EMA.

Responsibilities

• Develop and lead a comprehensive global regulatory strategy for LBL-051 across all development stages.
• Serve as the primary regulatory contact with the FDA and other global health authorities; lead agency interactions.
• Oversee preparation and submission of CTAs/INDs, amendments, clinical study reports, and responses to inquiries.
• Collaborate with Clinical Development, Clinical Operations, CMC, Nonclinical, and Commercial Planning/Strategy teams to align regulatory strategy with development plans.
• Provide regulatory input into trial design, protocol development, and study execution.
• Monitor the regulatory landscape and advise leadership on implications for the LBL-051 program.
• Support business development activities, including regulatory due diligence for fundraising or strategic transactions.
• Build and manage the regulatory affairs function, including oversight of CROs and consultants.
• Serve as a senior leader contributing to corporate strategy and milestones, including potential public market entry.

Skills

Regulatory strategy

IND/CTA submissions

FDA interactions

Biologics experience

Cross-functional leadership

Education

Bachelor’s degree

Advanced degree (PhD/MD/PharmD/MS)

Job description

Oblenio Bio is seeking a VP, Head of Regulatory Affairs to lead the global regulatory strategy for LBL-051, guiding clinical development and near-term milestones in a hybrid work setting. Reporting to the CEO and partnering with the CMO and leadership team, you will manage FDA interactions, prepare CTAs/INDs, and build a scalable regulatory function as the company grows.

This role combines strategic oversight with hands-on execution in a lean, fast-moving biotech, with potential for public