Director – Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee hands-on regulatory submission processes with minimal supervision (Director).

• Maintain close collaboration with CROs to guarantee timely submissions and effective tracking.

• Collaborate with Regulatory Operations and Medical Writing to ensure submissions comply with global regulatory standards and are delivered with high quality and on time.

• Offer strategic regulatory insights across nonclinical, CMC, clinical development, companion diagnostics, and lifecycle management initiatives.

• Stay updated on changing global regulatory requirements and relay potential impacts on company programs.

• Act as the primary regulatory representative for the assigned program(s).

• Guide regulatory planning for significant development milestones.

• Prepare for meetings with regulatory agencies, including Type B/C meetings typical of early-phase oncology programs.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific field.

• Advanced degree (PharmD, PhD, MS, or equivalent) is preferred.

• Around 10–12 years of regulatory affairs experience in biotechnology or pharmaceutical drug development, with direct experience in oncology drug development.

• Proven track record in leading regulatory submissions and strategies for oncology development programs, ideally covering first-in-human through early efficacy stages.

• Experience functioning as the regulatory lead for FDA interactions and significant regulatory submissions.

• Approximately 14+ years of progressive regulatory affairs experience, including oncology drug development (Senior Director).

• Approximately 18+ years of progressive regulatory affairs experience (Executive Director).

• Comprehensive understanding of FDA, EMA, ICH, and other major global regulatory requirements.

• Strong grasp of oncology drug development from First-in-Human through to commercialization.

• Familiarity with expedited regulatory pathways (Breakthrough Therapy, Fast Track, Accelerated Approval).

🏝️ Benefits

• Base pay

• Annual performance bonus

• Company equity

• Comprehensive health benefits