Head of Regulatory Affairs

SciPro; United States; Remote; USD 210,000 - 240,000; Full time

Job summary

A clinical-stage biotech company is seeking a Head of Regulatory Affairs to lead global regulatory strategies and execute NDA filings. This role requires a seasoned leader with extensive regulatory experience in biopharmaceuticals, particularly in immunology and inflammation. The candidate will be responsible for compliance, strategy, and team leadership as the company scales.

Qualifications

• 10+ years of regulatory experience in biopharmaceuticals, with 5+ years in leadership.
• Proven track record of leading NDA or BLA submissions.
• Expertise in small molecule drug development.

Responsibilities

• Lead and manage all regulatory activities, including strategy and submission of NDA filings.
• Serve as the primary contact with FDA and ensure compliance with regulatory requirements.
• Build and lead a high-performing regulatory team.

Skills

Regulatory Affairs

Leadership

Strategic Thinking

Interpersonal Skills

Education

PhD

PharmD

MS

Job description

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Head of Regulatory Affairs – Immunology & Inflammation

Location: Remote (US)

About Us

An exciting clinical-stage biotech company at the forefront of developing transformative therapies in immunology and inflammation. With two NDA submissions planned in the next 18 months, they are entering a critical phase of our growth—and they are seeking a seasoned leader to shape and execute their regulatory strategy at this pivotal time.

The Role

As Head of Regulatory Affairs, you will be a key member of their leadership team, responsible for driving global regulatory strategies and execution, with immediate focus on successful NDA filings. This is a rare opportunity to lead regulatory efforts across a dynamic portfolio targeting dermatological, autoimmune, and inflammatory diseases.

Key Responsibilities

• Lead and manage all regulatory activities, including strategy, planning, and submission of two NDA filings within 18 months
• Serve as the primary point of contact with FDA and other regulatory agencies
• Ensure compliance with all relevant regulatory requirements and guidelines
• Oversee preparation and submission of regulatory documents (NDA, BLA, INDs, amendments, etc.)
• Collaborate cross-functionally with clinical, CMC, nonclinical, and commercial teams
• Provide regulatory guidance throughout drug development lifecycle
• Build and lead a high-performing regulatory team as the company scales

Qualifications

• Proven track record of successfully leading at least one NDA or BLA submission (ideally through approval)
• 10+ years of regulatory experience in the biopharmaceutical industry, with at least 5 years in a leadership role
• Expertise in small molecule drug development is required
• Experience in immunology, dermatology, autoimmune, or inflammatory disease areas is essential
• Strong knowledge of FDA regulations and guidance; global experience (EMA/other) is a plus
• Strategic thinker with hands-on capabilities and strong interpersonal skills
• Advanced degree in life sciences or a related field preferred (PhD, PharmD, or MS)

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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