Orca is hiring a
Regulatory Affairs

Summary

Join Orca Bio as Sr. VP/Head of Regulatory Affairs to lead the company’s regulatory strategy and operations for its product pipeline, working closely with the executive team and serving as the primary liaison with health authorities including the FDA, EMA, and other global regulatory agencies.

Requirements

• Minimum of 15+ years of U.S. regulatory affairs experience as a proven leader within the biotech / pharmaceutical industry, or as a seasoned regulator, with additional global experience preferred
• Advanced degree (PharmD, PhD, MD) in biology/life sciences/or related discipline preferred
• Notable track record of successful regulatory leadership, preferably with a breadth of experience across multiple therapeutic areas and disease states, including clinical stage Oncology biologics/cell therapy products
• Viewed as an expert in the field, with the ability to identify existing regulatory pathways as well as helping to create, define and implement novel regulatory pathways to registration
• Prior experience with successful filing of late-stage regulatory submissions (BLA preferred)
• Prior experience working as head of regulatory in a small biotech environment with limited resources, including hands-on mindset, creative thinking and calculated risk taking
• Strong regulatory knowledge of drug development, including clinical trial requirements, trial design and data analysis, CMC, manufacturing, quality, post-marketing surveillance, marketing and sales

Responsibilities

• Define, implement, and oversee global regulatory strategies for all stages of product development (preclinical, clinical, and commercial)
• Collaborate with R&D, clinical development, and commercial teams to ensure regulatory alignment with business objectives
• Guide the development and submission of regulatory documents, including INDs, BLAs, MAAs, and CTA submissions
• Serve as the primary point of contact for regulatory agencies such as the FDA, EMA, and other global health authorities
• Lead preparation and participation in key regulatory meetings, including pre-IND, End-of-Phase 1/2, and pre-BLA meetings
• Facilitate effective communication with regulatory agencies to ensure alignment and timely feedback
• Build, mentor, and lead the Regulatory Affairs team, ensuring team members are prepared to address the complexities of a rapidly growing company
• Foster a culture of compliance, accountability, and innovation within the Regulatory Affairs function
• Oversee the development, compilation, and timely submission of all regulatory documentation to meet program timelines
• Ensure compliance with current global regulatory requirements and anticipate changes in regulatory landscapes
• Establish and maintain regulatory affairs systems, ensuring accurate record-keeping and data management

Benefits

• The anticipated annual salary range for this job will be based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market
• You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits
• Other perks include free daily lunches and snacks at our on-site locations