Associate Director, Regulatory Affairs Advertising and Promotion

Essential Duties and Responsibilities

• Review of promotional and medical material for an approved drug in the United States and a Class III medical device in Europe.
• Management of US and Global regulatory activities associated with advertising and promotion for company marketed products.
• Provide review of US and Global product and disease state materials/communications to support corporate goals and comply with applicable laws, regulations, and guidance.
• Contribute to and advise on the development of product messages and materials across multiple functional areas, including clinical trial materials.
• Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Collaborate cross-functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Help lead and assist in interactions with the FDA Office of Prescription Drug Promotion (OPDP), responsible for helping to maintain good working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters.
• Responsible for compliance with promotional material submissions to FDA on Form 2253.
• Maintain vigilance regarding FDA promotional enforcement activities to, in partnership with management, provide stakeholders with updates and impact of enforcement activities.
• Identify process improvement for promotional review activities that would enable the establishment of portfolio-wide standardization of policies.
• Support regulatory affairs department in other tasks as needed.

Qualifications

• A BS or MS degree in physical or life sciences required.
• Must have at least 5 years drug with Regulatory Advertising and Promotion.
• Must have knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with focus in advertising and promotion.
• Experience with pharmaceutical products required, drug/device combination product experience a plus.
• Experience working directly/indirectly with the FDA, specifically OPDP/APL is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APL.
• Excellent written/verbal communication skill.
• Understanding of clinical trial recruitment materials and labeling regulations.
• Experience working across multi-disciplinary levels, functions and regions is required.
• Must be team oriented, with the ability to work well with diverse cross-functional teams.
• Must possess strong analytical and process skills and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
• Must possess strong verbal and written communication skills.
• Willingness to travel.