Head of Regulatory Affairs - Al Solutions : Job Details

About My Client

My client is at the forefront of oncology innovation, particularly in hematology and oncology, to improve outcomes for patients with relapsed or refractory cancers. With a robust intellectual property portfolio, pending patents, and a strong pipeline, my client is dedicated to transforming cancer care.

Role Overview

They are seeking an experienced and strategic Head of Regulatory Affairs to lead regulatory strategy and oversee all regulatory activities for their cutting-edge portfolio. This high-impact role will be responsible for guiding the development and execution of regulatory submissions, including interactions with the FDA and other regulatory agencies for their oncology programs.

Key Responsibilities

• Regulatory Strategy Development: Design and implement regulatory strategies for their ARCs and targeted therapies across all stages of development.
• FDA and International Agency Interactions: Act as the primary regulatory contact, establishing effective communication with agencies to expedite review processes and approvals.
• Leadership and Cross-functional Collaboration: Partner with R&D, clinical, and commercial teams to integrate regulatory perspectives into clinical development plans.
• Pipeline Advancement: Lead regulatory efforts for key products, ensuring all submissions meet high-quality standards.

Qualifications

• 15+ years in Regulatory Affairs, with proven expertise in oncology and biologics.
• Deep knowledge of regulatory requirements, including IND, BLA, and orphan drug applications.
• Strong experience in FDA engagement, particularly in hematology and oncology therapies.
• Advanced degree (MS, PhD, or MD) in life sciences, along with strategic thinking and leadership skills.

Why Join My Client?

My client offers an opportunity to lead in a dynamic, mission-driven environment focused on transformative cancer treatments. As Head of Regulatory Affairs, you will play a pivotal role in driving breakthrough therapies and influencing regulatory strategies in an innovative biotech setting.