Head of Regulatory Affairs

Head of Regulatory Affairs

Position Overview

A commercial-stage biotech focused on neurodegenerative diseases, is seeking a seasoned regulatory leader to drive global regulatory strategies for approved products, ensuring compliance and supporting lifecycle management activities. This role will primarily focus on post-approval regulatory work, including label expansions, geographic submissions, and promotional compliance, with the opportunity to contribute to pre-approval development programs as the pipeline advances.

Key Responsibilities

• Post-Approval Regulatory Leadership:
  • Manage global lifecycle submissions (variations, renewals, labeling updates) for marketed products.
  • Support geographic expansion into new regions (e.g., EU, ROW).
• Advertising & Promotion Compliance:
  • Provide regulatory oversight in PRC/MLR meetings for promotional materials and advertising campaigns.
• Global Strategy & Agency Engagement:
  • Serve as primary contact with health authorities for post-marketing commitments and approvals.
• Cross-Functional Collaboration:
  • Partner with Medical Affairs, Commercial, and Legal teams to ensure regulatory alignment with business objectives.
• Regulatory Intelligence:
  • Monitor evolving global regulations impacting post-marketing and pre-approval activities.
• Pipeline Support:
  • Contribute to regulatory strategies for late-stage development programs and future submissions.

Qualifications

• Experience: 10+ years in Regulatory Affairs, with significant expertise in post-marketing regulatory activities and global lifecycle management.
• Expertise: Strong knowledge of FDA, EMA, and international regulatory frameworks; experience with PRC/MLR promotional review processes.
• Track Record: Proven success in securing approvals for label expansions and geographic launches.
• Therapeutic Area: Rare disease and/or neurodegenerative experience preferred.
• Skills: Leadership, strategic thinking, and ability to manage complex global projects.