Director, Regulatory Advertising & Promotion

About the Role

The director will be responsible for reviewing and approving promotional materials to ensure compliance with FDA regulations, PhRMA guidelines, and other relevant codes of practice. They will also establish and maintain productive working relationships with regulatory agencies, including the Office of Prescription Drug Promotion (OPDP) at FDA. With several marketed products and a diverse pipeline, the company is poised for growth, and this role is critical to its success.

The ideal candidate will have a strong background in regulatory advertising and promotion, with excellent communication and interpersonal skills. They will be able to work effectively in a matrix organization, prioritize tasks, and adapt to changing priorities. The ability to make complex decisions and defend difficult positions is essential, as well as the ability to learn new therapeutic areas when necessary.

What You Will Do

• Review and approve promotional materials, including advertising and promotional labeling, to ensure compliance with regulatory requirements
• Develop and maintain productive working relationships with regulatory agencies, including the OPDP at FDA
• Establish a working relationship with the OPDP at FDA and serve as an internal regulatory expert on FDA regulations
• Align with regulatory colleagues on strategies to optimize the commercial success of products
• Develop and maintain compliant promotional materials, including sales aids, websites, and social media content
• Provide training and guidance to junior staff and external consultants on regulatory advertising and promotion
• Manage the review and approval of promotional materials, ensuring on-time and accurate submission to regulatory agencies
• Collaborate with marketing, legal, and medical affairs teams to develop and maintain compliant promotional materials
• Stay up-to-date with the latest FDA regulations, guidance, and enforcement trends governing the promotion of prescription therapies

What We Are Looking For

• Advanced degree in a scientific discipline, preferably in pharmacy, medicine, or a related field
• At least 8 years of experience in the biotech or pharmaceutical industry, with a minimum of 8 years focused on regulatory advertising and promotion
• Strong knowledge of FDA regulations, including 21 CFR Part 312 and 21 CFR Part 314
• Experience with PhRMA guidelines and other relevant codes of practice
• Excellent verbal and written communication skills, with the ability to influence others internally and externally
• Strong interpersonal skills, with the ability to work effectively in a matrix organization
• Ability to prioritize tasks, adapt to changing priorities, and make complex decisions
• Experience with managing and developing talent, including training and mentoring junior staff

Nice to Have

• Experience with creating and reviewing SOPs and department operating procedures
• Knowledge of Excel and other software applications relevant to the role
• Experience working in a remote or virtual environment
• Certification in regulatory affairs, such as RAC or CCRP

Benefits and Perks

• Competitive salary and benefits package
• Opportunity for merit-based salary increases and short-term incentive plan participation
• Eligibility for 401(k) plan and other retirement savings options
• Medical, dental, and vision insurance, as well as life insurance
• Paid time off and holidays, with flexible work arrangements
• Professional development opportunities, including training and education programs
• Access to cutting-edge technology and software applications
• Collaborative and dynamic work environment with a team of experienced professionals

• Develop a strong understanding of FDA regulations, including 21 CFR Part 312 and 21 CFR Part 314, to stand out as a candidate.
• Create a portfolio of your work, including examples of promotional materials you have reviewed and approved, to demonstrate your expertise.
• Practice your communication skills, including verbal and written communication, to effectively influence others internally and externally.
• Research the company and its products, including its diverse pipeline and marketed products, to demonstrate your knowledge and interest in the role.
• Be prepared to discuss your experience with regulatory advertising and promotion, including your experience with PhRMA guidelines and other relevant codes of practice.
• Highlight your ability to work effectively in a matrix organization, prioritize tasks, and adapt to changing priorities.
• Be prepared to negotiate your salary and benefits package, based on your experience and qualifications.