Associate Director, Global Regulatory Labeling, Ad Promo

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $155k - $190k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Kailera Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2024

🔥 Funding within the last year

💰 $600M Series B - Kailera Therapeutics on 2025-10

Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive clinical trial results in obesity in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com.

📋 Description

• Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use, primary and secondary carton labeling, and promotional labeling • Provide regulatory guidance on product labeling throughout development, registration, launch, and post-approval lifecycle management • Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams • Support labeling negotiations with the FDA and manage 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 review process and collaborate with the MLR process owner • Ensure compliance with FD&C Act requirements, FDA advertising and promotion regulations, OPDP guidance and enforcement trends, PhRMA Code requirements, and company policies and procedures • Provide regulatory recommendations for compliant and effective non-promotional and promotional communications • Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices • Contribute to SOPs, policies, and governance processes

🎯 Requirements

• Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling, or a bachelor’s degree with 10+ years • Established working knowledge of regulatory guidelines and regulations (US and international), particularly product labeling and advertising promotion • Deep knowledge of the integrated drug development process • Ability to find solutions and alternatives through teamwork resulting in positive business outcomes • Ability to assess and manage risk in a highly regulated environment • Strong written, spoken, and presentation communication • Desire to grow a career in the pharmaceutical industry, willingness to learn, and enthusiasm for new opportunities • Travel expected (10–15%) • Bachelor’s degree with 10+ years of experience or advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience • New hires must satisfy employment eligibility verification through E-Verify

🏖️ Benefits

• Comprehensive health coverage • Flexible time off • Paid holidays • Year-end shutdown • Monthly wellness stipend • Generous 401(k) match • Tuition reimbursement • Commuter benefits • Disability insurance • Life insurance • Annual bonus opportunities • Equity grants