Director, Advertising & Promotion

Zenas BioPharma is a global biopharmaceutical company seeking a Director, Advertising & Promotion to lead regulatory strategy and oversight for product labeling and promotional activities.

Requirements

• Bachelor’s degree required; advanced degree, preferably in a scientific, healthcare, legal, or related field preferred.
• A minimum of 10 years’ regulatory affairs experience, including significant experience in advertising, promotion, and labeling for pharmaceutical and/or biologic products.
• Prior experience in developing both US and global advertising and promotion.
• Deep understanding of FDA regulations, guidance, and enforcement practices related to prescription drug labeling, advertising, and promotion.
• Proven ability to provide strategic regulatory advice and negotiate effectively with internal and external stakeholders on complex issues.
• Experience managing OPDP submissions, including advisory comment requests, time-of-first-use, and 30-day accelerated approval submissions.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Independently motivated, detail oriented, and good problem-solving ability.
• Excellent written and verbal communication skills.
• Experience interacting with key functional stakeholders (clinical development, medical affairs, legal, commercial).
• Proficiency with Microsoft Office applications and familiarity with document management and regulatory information systems (e.g., Veeva PromoMats) preferred.

Benefits

• Annual performance bonus
• Equity
• Full range of benefits
• Other incentive compensation plans