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