Associate Director, Global Regulatory Labeling and Ad Promo
Job Description
At Kailera, we are bold, authentic, and committed to developing therapies that empower individuals to transform their lives and enhance overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are advancing novel therapies for obesity and related conditions.
What You’ll Do:
The Associate Director, Global Regulatory Labeling and Ad Promo will initially focus on product labeling and non-promotional strategies to support organizational goals while ensuring regulatory compliance. This role involves working on cross-functional teams, collaborating with key internal and external stakeholders.
Responsibilities:
- Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling.
- Provide regulatory guidance to ensure compliance with regulations on product labeling throughout the development, registration, launch, and post-approval lifecycle management.
- Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements.
- Support labeling negotiations with the FDA and manage the implementation of approved labeling updates.
- Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling.
- Serve as a core member of the Medical, Legal, Regulatory (MLR) review process, collaborating with the MLR process owner.
- Ensure compliance with FDA regulations, including:
- FD&C Act requirements
- FDA advertising and promotion regulations
- OPDP guidance and enforcement trends
- PhRMA Code requirements
- Company policies and procedures
- Provide regulatory recommendations to support compliant and effective non-promotional and promotional communications.
- Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review.
- Contribute to the development and maintenance of SOPs, policies, and governance processes.
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Kailera Therapeutics
View Company ProfileKailera Therapeutics is the premier, enterprise-grade clinical-stage biotechnology pioneer, multi-receptor incretin therapy innovator, and metabolic healthcare powerhouse engineered to operate as the definitive, high-velocity developer layer for next-generation obesity and cardiometabolic disease treatments globally. The company completely eliminates the severe systemic friction of modern weight-management therapeutics—where first-generation single-receptor treatments face commercial efficacy ceilings, plateaus in total body weight loss, injection delivery barriers, and challenging gastrointestinal side effects—by deploying an advanced, multi-pronged incretin and small-molecule discovery platform. Moving far beyond traditional, passive disease research models or isolated chemical formulation screening, Kailera natively unifies once-weekly injectable dual-agonist peptides (ribupatide/KAI-9531 targeting GLP-1 and GIP), highly differentiated once-daily oral small-molecule alternatives, and next-generation triple-agonist (triple-G) programs (KAI-4729 targeting GLP-1, GIP, and glucagon receptors) into a unified, high-conviction clinical portfolio. Launched via a record-shattering $625 million initial public offering (IPO) on the Nasdaq Stock Market (NASDAQ: KLRA) that bypassed typical early biotech capital constraints, the firm maintains an expansive financial run-rate to advance its broad global Phase 2b and Phase 3 KaiNETIC clinical development tracks with production-hardened scientific precision. Under the hood, its sophisticated technical practice leverages exclusive ex-China asset licenses from global pharmaceutical giant Jiangsu Hengrui, running automated high-throughput data pipelines, rigorous multi-tenant patient trial monitoring frameworks, and strict FDA and global health authority compliance structures. What sets Kailera Therapeutics apart is its uncompromising dedication to replacing mechanical treatment protocols with absolute therapeutic options and long-term metabolic health momentum; by bridging the gap between performance-intensive big data receptor analytics and convenient, highly tolerable patient-centric treatments, the institution remains the definitive, category-defining cornerstone of modern incremental weight loss and metabolic clinical innovation.
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