Director, Advertising & Promotion and Labeling

Zenas BioPharma•Waltham, MA

75d•Hybrid

About The Position

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation! Position Summary: The Director, Advertising & Promotion and Labeling, will lead the regulatory strategy and oversight for Zenas' product labeling and promotional activities. This individual will serve as the company's subject matter expert on FDA regulations, guidance, and enforcement trends related to advertising, promotion, and labeling. The Director will ensure that all promotional and non-promotional materials meet regulatory requirements, drive labeling strategies across the product lifecycle, and collaborate closely with cross-functional partners to support both development and commercial objectives. This position will report to the Executive Director, Global Regulatory Affairs.

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, promotion, and labeling regulatory strategies.
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.
Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.

Responsibilities

Lead regulatory strategy and execution for advertising, promotion, and labeling activities across Zenas' portfolio.
Collaborate with cross-functional teams (Clinical, Medical, Legal, Compliance, and Commercial) to ensure labeling and promotional claims are scientifically and legally sound.
Serve as the primary regulatory representative on review of promotional and non-promotional materials and act as the liaison with the FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB).
Provide strategic regulatory input on promotional materials to ensure compliance with FDA advertising and promotion regulations.
Oversee the development, review, and maintenance of core labeling documents, including the Company Core Data Sheet (CCDS), US Prescribing Information (USPI), patient labeling, and international equivalents.
Develop and implement systems, policies, and procedures to support efficient labeling and promotional material development, review, and approval processes.
Monitor changes in FDA regulations, guidance, and enforcement trends, communicating key updates and implications to stakeholders.
Support the integration of regulatory considerations into marketing strategies, product positioning, and external communications.
Oversee the submission activities to ensure compliance with FDA regulations for advertising and promotional materials.
Perform other regulatory responsibilities as assigned to support departmental and corporate goals.