Head of Regulatory Affairs

Barrington James; United States; Remote; USD 220,000 - 330,000; Part time

Job summary

A leading biotech company is seeking a Freelance Head of Regulatory Affairs specializing in oncology on a part-time basis. Key responsibilities include developing regulatory strategies, leading FDA interactions, and ensuring compliance with regulations. Ideal candidates have extensive experience in the biopharmaceutical industry, particularly with oncology, and possess strong leadership and strategic skills.

Qualifications

• Minimum 10 years of regulatory affairs experience in the biopharmaceutical industry focused on oncology.
• Prior experience leading U.S. INDs and global regulatory strategy.
• In-depth knowledge of U.S. regulatory requirements.

Responsibilities

• Develop and implement regulatory strategies for oncology programs.
• Lead regulatory interactions with the FDA and global health authorities.
• Provide strategic guidance to cross-functional teams.

Skills

Leadership

Strategic Thinking

Project Management

Education

PhD, PharmD, or MS in life sciences

Job description

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Recruiting for a Freelance Head of regulatory affairs position on a part time basis within a small oncology focused biotech.

>1099/LLC

>0-20 hours per week

>12 month contract

>Prior oncology experience is a must

>BA/masters

Please see below information:

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for oncology programs, including INDs, amendments, and regulatory submissions (e.g., Fast Track, Breakthrough Therapy Designation).
• Lead regulatory interactions with the FDA and other global health authorities; prepare briefing books and coordinate meeting logistics.
• Provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Nonclinical, and Quality.
• Oversee preparation and submission of regulatory documents (INDs, safety updates, annual reports, etc.).
• Ensure regulatory compliance with applicable laws, regulations, and guidelines.
• Serve as the primary regulatory representative on the leadership team and project teams.
• Advise on regulatory implications of clinical trial designs and endpoints.
• Contribute to corporate strategy, partnering discussions, and due diligence activities as needed.

Qualifications

• Advanced degree (PhD, PharmD, or MS preferred) in life sciences or related field.
• Minimum of 10 years of regulatory affairs experience in the biopharmaceutical industry, with a strong focus on oncology.
• Prior experience leading U.S. INDs and global regulatory strategy; experience with FDA oncology division is highly preferred.
• In-depth knowledge of U.S. regulatory requirements; ex-U.S. experience (EMA, MHRA, etc.) a plus.
• Proven ability to lead regulatory interactions and manage submissions in a small or mid-sized biotech environment.
• Strong leadership, strategic thinking, and project management skills.
• Comfortable working in a lean, fast-paced environment with a hands-on approach.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Science, Strategy/Planning, and Writing/Editing

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

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