Senior Director, Advertising and Promotion Regulatory Affairs

职位描述

The Senior Director, Regulatory Affairs, Advertising and Promotion is responsible for developing and executing a regulatory strategy that enables the global business to meet its needs in full compliance. This role is based at Kite, a Gilead Company, in Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs.

Responsibilities:

• Lead, develop, and mentor a team of regulatory advertising and promotion professionals, including a Review team, and an Operations team.

• Oversee the financial accountability and resourcing responsibilities for assigned staff.

• Advising Company stakeholders on regulatory changes, policies, and enforcement actions that may impact promotional activities.

• Assume a leadership role in advising cross-functional stakeholders on the promotional regulatory impact of new campaign concepts, target, or product labeling, and to provide strategic regulatory guidance on corporate communications and appropriate pre-approval and/or disease education communications with minimal oversight.

• Review/approve promotional, corporate, and other non-promotional materials focused on cellular therapy for cancer to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.

• Represent the regulatory perspective at and chairing the executive promotional review committee (EPRC) which includes cross functional partners from Commercial, Medical Affairs, and Legal

• Enhances collaboration across a matrixed organization while developing and maintaining constructive relationships.

• May serve as the company's regulatory liaison to the FDA’s Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.

• Characterize the advertising and promotion perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues.

• Review and interpret enforcement letters, keep current with industry changes relating to advertising and promotion, interpret new Guidance to Industry and evaluate related internal policies/best practices and processes.

Basic Qualifications

• Advanced Degree: Advanced scientific degree (e.g., MD, PharmD, PhD) with 10+ years of relevant experience; OR

• Master’s Degree: Master’s Degree with 12+ years of relevant experience; OR

• Bachelor’s Degree: Bachelor’s Degree with 14+ years of relevant experience

Preferred Qualifications:

• An advanced degree and at least 10 years of experience in regulatory review of promotional materials for prescription drug and/or biologic products

• Relevant oncology experience; cell/gene therapy experience

• A solid understanding of clinical study design, statistical analyses for promotional claims assessment, and comprehensive experience with labeling regulations and U.S./global promotional reviews.

• Strong decision-making and problem-solving skills, demonstrated by complex reasoning and risk management assessments.

• A proven track record in influencing cross-functional teams and engaging effectively with senior management.

• Superior project management and presentation skills, with the ability to work autonomously with minimal oversight from a senior regulatory affairs professional

• Expert level of applied knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments.

• Knowledgeable resource for regulatory advice on promotional, corporate, and other non-promotional initiatives in other departments

• Direct experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch