Associate Director, Regulatory Affairs - Advertising and Promotion

职位描述

The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in support of patients and in a compliant manner.  Responsibilities pertain primarily to US marketing activities focused in cell therapy. The Associate Director will be based in Santa Monica, CA or Remote and will report to a Director in Regulatory Affairs, Advertising and Promotion.

Responsibilities

• Review promotional, corporate and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices
• Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal)
• Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling
• May provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight
• Serve as a liaison to the FDA’s Advertising and Promotional Labeling Branch for respective product(s) and help ensure materials are submitted to FDA in a timely manner
• Review and approve promotional, corporate and other non-promotional materials for relevant products and associated therapeutic areas
• Characterize the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings and provide training to cross-functional colleagues including members of the PRC
• Review and interpret enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new guidances to Industry and evaluate related internal policies/best practices and processes
• Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities

Basic Qualifications

Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years of regulatory, project management, marketing, or operations experience

OR

Master’s Degree and 8+ years of regulatory, project management, marketing, or operations experience

OR

Bachelor’s Degree and 10+ years of regulatory, project management, marketing, or operations experience

OR

High School Degree and 14+ years of regulatory, project management, marketing, or operations experience

Preferred Qualifications

• Advanced degree
• 10+ years of relevant experience
• 6+ years of experience in regulatory review of promotional materials for prescription drug and/or biologic products
• Oncology, immunology, and/or other relevant therapeutic area experience
• Excellent verbal and written communication skills and interpersonal skills
• Capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders
• Ability to perform work with minimal direction
• Knowledgeable resource for commercial 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
• Ability to understand and evaluate all perspectives and provide expert commercial regulatory guidance