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Zenas BioPharma · 9 hours ago

Director, Advertising & Promotion

Waltham, MA

Full-time

Hybrid

Director/Executive

$183K/yr - $229K/yr

10+ years exp

Zenasbio is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases. The Director, Advertising & Promotion, will lead the regulatory strategy and oversight for product labeling and promotional activities, ensuring compliance with FDA regulations while collaborating with cross-functional teams to support development and commercial objectives.

BiopharmaHealth CarePharmaceutical

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

Qualification

Regulatory affairs experienceFDA regulations expertiseAdvertisingPromotionStrategic regulatory adviceMicrosoft Office proficiencyLeadership skillsCommunication skillsProblem-solving abilityTeam collaborationDetail oriented

Required

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)

Preferred

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