Regulatory Affairs Leader for a Biotech Pioneer

4 days ago


Menlo Park, California, United States Lifelancer Full time
Unlock Career Opportunities at Orca Bio

We are driven by a passion for science and compassion for patients. Our goal is to ensure that our treatments are accessible to all who need them.

As a leading biotech company, we value excellence in our work and the chance to unlock a better quality of life for our patients. We take tremendous responsibility for achieving this goal.

About the Role

The Head of Regulatory Affairs will lead our regulatory strategy and operations, working closely with the executive team to ensure alignment with business objectives. This role involves guiding the development and submission of regulatory documents, including INDs, BLAs, MAAs, and CTA submissions.

You will serve as the primary point of contact for regulatory agencies such as the FDA, EMA, and other global health authorities, facilitating effective communication and timely feedback.

This is an excellent opportunity for a seasoned regulator or industry professional to join our team and contribute to the success of our product pipeline.

Responsibilities
  • Collaborate with R&D, clinical development, and commercial teams to ensure regulatory alignment with business objectives.
  • Develop and submit 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.
  • Foster a culture of compliance, accountability, and innovation within the Regulatory Affairs function.
Requirements
  • A minimum of 12+ years of regulatory affairs experience, including 8+ years in a leadership capacity within the biotech/pharmaceutical industry or as a seasoned regulator.
  • An advanced degree (PharmD, PhD, MD) in biology/life sciences/or related discipline is strongly preferred.
  • A 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.
Salary and Benefits

The anticipated annual salary range for this job is between $180,000 and $220,000, based on prior experience in the role/industry, education, location, internal equity, and other job-related factors. You will also 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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