Associate Director, Regulatory Affairs Labeling, Advertising and Promotion

Position Overview

• Location Type: Primarily Remote (Some travel may be required)
• Job Type: Regular, Full-Time Employee
• Salary: Not specified

Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. The goal is to provide significantly better survival rates with dramatically fewer risks for patients with blood cancer. Reporting to the Head of Regulatory Affairs, the Associate Director will be responsible for the development and approval of all US promotional materials and serve as the promotional regulatory expert, collaborating with marketing, legal, and medical teams to ensure promotional practices align with regulatory guidelines, company policies, and business objectives. The role also involves leading and/or contributing to post-approval regulatory submissions.

Requirements

• Experience in Regulatory Affairs, preferably within the biotechnology or pharmaceutical industry.
• Strong understanding of FDA regulations, guidelines, and enforcement actions related to pharmaceutical advertising and promotion.
• Ability to develop and implement commercial regulatory strategies.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
• Experience with promotional material review and approval processes.
• Familiarity with post-approval regulatory submissions (e.g., phase 3b/4 studies, amendments).

Responsibilities

• Define commercial regulatory strategies and ensure all corporate communications are compliant with regulatory standards.
• Provide regulatory guidance on new marketing concepts, messaging, and campaigns.
• Review and approve all US promotional materials, working closely with cross-functional teams to ensure compliance and alignment with U.S. promotional regulations, corporate standards, and business objectives.
• Manage the strategy and operational aspects of regulatory labeling for Phase 3 and commercial assets.
• Serve as the liaison and manage correspondence with FDA’s promotional review divisions and provide input on application labeling negotiations.
• Lead the strategy, coordination, and execution of post-approval regulatory submissions (e.g., phase 3b/4 studies, amendments, aggregate annual reporting).
• Maintain a continued awareness of FDA regulations, guidance documents, and enforcement actions.
• Develop and maintain Regulatory Affairs SOPs.

Application Instructions

• Not specified in the provided text. Please refer to Orca Bio's careers page for application instructions.

Company Information

• Company: Orca Bio
• Industry: Biotechnology
• Mission: To redefine the transplant process by developing next-generation cell therapies to provide significantly better survival rates with dramatically fewer risks for patients with blood cancer.
• Note: Some travel may be required as needed.