Hybrid Global Regulatory Strategy Director, Immunology

Initial Therapeutics, Inc.; Boston (MA); Hybrid; USD 242,000 - 313,000; Full time

Benefits offered by this job

Flexible work arrangements / hybrid

Job summary

Beeline Medicines is seeking a Senior Director, Regulatory Strategy - Global Regulatory Lead to steer integrated regulatory plans across major jurisdictions and guide teams through IND/CTA, NDA/BLA filings and pediatric development. This leadership role emphasizes cross-functional collaboration and proactive regulatory insight.

The position focuses on autoimmune indications within immunology/inflammation, requiring at least 12 years in regulatory affairs and a track record of strategic agency

Qualifications

• Advanced degree required in life sciences.
• Minimum of 12+ years regulatory affairs experience with 5–7 years global strategy leadership.
• Deep expertise across FDA/EMA for biologics and small molecules.
• Experience leading Health Authority interactions and translating feedback into development plans.

Responsibilities

• Develop global regulatory strategies for I&I programs from pre-IND to post-approval.
• Lead Health Authority interactions and strategic development of filing plans.
• Create and maintain integrated regulatory development plans (iRDPs) and timelines.
• Lead IND/CTA, NDA and BLA submissions and pediatric development planning.
• Collaborate with cross-functional teams to align regulatory strategy with development goals.

Skills

Regulatory strategy

Global filings

FDA/EMA experience

Leadership

Cross-functional collaboration

Education

Advanced degree (PhD/PharmD/Master) in life sciences

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Strategy - Global Regulatory Lead to steer integrated regulatory plans across major jurisdictions and guide teams through IND/CTA, NDA/BLA filings and pediatric development. This leadership role emphasizes cross-functional collaboration and proactive regulatory insight.

The position focuses on autoimmune indications within immunology/inflammation, requiring at least 12 years in regulatory affairs and a track record of strategic agency