Associate Director, Regulatory Affairs - Advertising​/Promotion

Position: Associate Director, Regulatory Affairs - Advertising/Promotion

Location: Boston, MA

Job : 112983

# of Openings: 1

Mann Kind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, Mann Kind aims to deliver therapies designed to fit seamlessly into daily life.

At Mann Kind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.

The Associate Director, Regulatory Affairs will be responsible for coordinating and completing regulatory review and approval of all commercial materials, representing the Regulatory team on both the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.

In addition, this position oversees all regulatory operational management of commercial materials (Veeva Vault, electronic document management system, applicable processes and SOPs) and will prepare all required promotional material submissions to regulatory authorities and coordinate those submissions with the regulatory operations team.

Additional key job duties and responsibilities are as detailed below and will include:

• Providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives,
• Maintaining current knowledge and understanding of FDA regulations/guidelines PhRMA guidelines and company policy and sharing new developments with impacted team members,
• Informs teams for assigned products and projects on implementation of compliant product labeling and communications.
• This position requires an ability to understand and evaluate competing perspectives and provide clear risk-based regulatory guidance based on internal and external guidelines.
• Contribute to the regulatory review of all labeling, and support regulatory strategy team during label negotiations to evaluate the impact of revisions on commercial and marketing strategy.

• Review, approve, and provide regulatory oversight for product labeling, advertising, promotional materials, and other commercial communications to ensure compliance with applicable FDA regulations, CFR requirements, company policies, industry standards, and other relevant regulatory requirements.
• Lead and manage promotional review processes and associated operational systems, including Veeva Vault Promo Mats, electronic document management systems, workflows, SOPs, and governance processes supporting the review and approval of commercial materials.
• Prepare, compile, and coordinate required regulatory submissions for promotional materials, including FDA Form 2253 submissions, in collaboration with Regulatory Operations.
• Develop and implement regulatory labeling and promotion strategies for new, existing, and modified products, ensuring alignment between approved labeling, promotional messaging, and business objectives.
• Review and approve labeling, promotional claims, and marketing content to ensure scientific accuracy, claim substantiation, fair balance, appropriate risk communication, and consistency with approved prescribing information and regulatory commitments.
• Support the development, maintenance, and implementation of product labeling, claims support documentation, and regulatory records, ensuring materials remain current with approved indications, safety information, regulatory changes, and business needs.
• Assess evolving regulations, guidance documents, enforcement actions, and industry trends and provide recommendations regarding their impact on labeling, advertising, promotion, and commercial practices.
• Develop and document regulatory positions, risk assessments, and compliance recommendations that support sound business decisions while maintaining regulatory compliance.
• Serve as the primary regulatory liaison for advertising and promotion matters with FDA Office of…