Regulatory Affairs Executive

4 days ago


Menlo Park, California, United States Lifelancer Full time

Join Orca Bio, a late-stage biotechnology company redefining the transplant process with next-generation cell therapies. As our Head of Regulatory Affairs, you will lead our regulatory strategy and operations.

Role Overview

This role is ideal for a seasoned regulator or leader with 12+ years of experience in regulatory affairs within the biotech/pharmaceutical industry. You will play a crucial part in shaping our U.S. and global regulatory plans for product pipeline development.

Key Responsibilities:
  • Regulatory Strategy: Collaborate with R&D, clinical development, and commercial teams to ensure regulatory alignment with business objectives.
  • Document Submission: Guide the development and submission of regulatory documents, including INDs, BLAs, MAAs, and CTA submissions.
  • Liaison with Health Authorities: Serve as the primary point of contact for regulatory agencies such as the FDA, EMA, and other global health authorities.
  • Meeting Preparation: Lead preparation and participation in key regulatory meetings, including pre-IND, End-of-Phase 1/2, and pre-BLA meetings.
Requirements:
  • A minimum of 12+ years of regulatory affairs experience, including 8+ years in a leadership capacity within the biotech/pharmaceutical industry.
  • An advanced degree (PharmD, PhD, MD) in biology/life sciences/or related discipline strongly preferred.
  • A notable track record of successful regulatory leadership, preferably with a breadth of experience across multiple therapeutic areas and disease states.
Compensation and Benefits

The anticipated annual salary range for this role is $250,000-$350,000 based on prior experience, education, location, internal equity, and other job-related factors as permitted by law. Additionally, you will be eligible to receive pre-IPO equity, medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.



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