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Full-Time

SVP/Head – Regulatory Affairs

Confirmed live in the last 24 hours

Orca Bio

Orca Bio

51-200 employees

Develops and commercializes cell therapies

Healthcare
Biotechnology

Senior, Expert

Remote in USA

Category
Risk & Compliance
Legal & Compliance
Required Skills
Sales
Communications
Marketing
Data Analysis
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.
  • The successful candidate must have 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.
  • Work closely with Clinical, CMC, Quality, and Commercial teams to integrate regulatory strategy into product development plans.

Orca Bio operates in the biotechnology field, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company aims to enhance these therapies to make them safer and more effective, ultimately improving patient outcomes. Orca Bio's products are designed for healthcare providers who administer these therapies to patients as part of their treatment plans. Unlike many competitors, Orca Bio emphasizes a strong team culture and values communication with stakeholders, keeping them informed about the company's progress and developments. The goal of Orca Bio is to significantly impact healthcare by advancing cell therapy treatments for conditions that currently have limited options.

Company Stage

Series D

Total Funding

$375M

Headquarters

Menlo Park, California

Founded

2016

Growth & Insights
Headcount

6 month growth

14%

1 year growth

18%

2 year growth

38%
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Simplify's Take

What believers are saying

  • Orca Bio's promising clinical data, including high relapse-free survival rates, highlight the potential for curative treatments in challenging patient groups.
  • The company's participation in prestigious conferences like the J.P. Morgan Healthcare Conference and the American Society of Hematology Annual Meeting underscores its industry recognition and thought leadership.
  • Orca Bio's strong team culture and commitment to employee value make it an attractive workplace for talented individuals in the biotechnology field.

What critics are saying

  • The competitive landscape in cell therapy and biotechnology requires continuous innovation to maintain a leading position.
  • Clinical trials and regulatory approvals are inherently risky and can lead to delays or failures, impacting the company's progress and financial stability.

What makes Orca Bio unique

  • Orca Bio's focus on high-precision cell therapies for cancer, autoimmune diseases, and genetic blood disorders sets it apart in the biotechnology sector.
  • Their proprietary single-cell precision manufacturing platform offers uniquely-defined products that aim to transform allogeneic cell therapy.
  • Orca Bio's investigational therapies, such as Orca-T and Orca-Q, demonstrate significantly better outcomes with fewer risks compared to standard treatments.