Orca Bio · 4 days ago

Head, Regulatory Affairs

Menlo Park, CA

Full-time

Remote

Director/Executive

12+ years exp

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Responsibilities

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.

Qualification

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Regulatory Affairs LeadershipU.S. Regulatory ExperienceGlobal Regulatory StrategyIND SubmissionBLA SubmissionClinical Trial RequirementsDrug Development KnowledgeOncology Biologics ExperienceAdvanced DegreeRegulatory ComplianceData Analysis

Required

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.

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.

Prior experience interacting with the FDA, 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 in a clinical regulatory leadership role, ideally in a small biotech environment with limited resources.

Hands-on mindset, demonstrated competencies in creative thinking and calculated risk taking.

High emotional intelligence, ability to effectively lead and drive the team to deadlines, with strong leadership competencies.